ApexPro Telemetry Server System. Also identified as Modification To: ApexPro Telemetry System an...

FDA Device Recall #Z-0175-2020 — Class II — August 30, 2019

Recall Summary

Recall Number Z-0175-2020
Classification Class II — Moderate risk
Date Initiated August 30, 2019
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm GE Healthcare, LLC
Location Waukesha, WI
Product Type Devices
Quantity 22,438 (17,971 US; 4,467 OUS) devices total

Product Description

ApexPro Telemetry Server System. Also identified as Modification To: ApexPro Telemetry System and ApexPro FH Telemetry System - Product Usage: These systems are typically deployed in sub acute care areas in hospitals or clinical sites where patient mobility can enhance the effectiveness of the medical procedures administered.

Reason for Recall

May not provide visual and/or audible alarms at the CARESCAPE Central Station or Clinical Information Center monitor for ECG arrhythmias, ECG LEADS FAIL or Pulse Oximetry (SpO2) under certain conditions.

Distribution Pattern

Worldwide distribution - US Nationwide including the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. The countries of ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, BERMUDA, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CROATIA, CYPRUS, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, ECUADOR, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, GUAM, GUATEMALA, HONDURAS, HONG KONG, HUNGARY, INDIA, Indonesia, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, Korea (Republic of), KUWAIT, LATVIA, LEBANON, LIBYA, LITHUANIA, MACEDONIA, Malaysia, MEXICO, MOROCCO, Myanmar, NETHERLANDS, New Zealand, NORWAY, PANAMA, PHILIPPINES, POLAND, PORTUGAL, PUERTO RICO, QATAR, ROMANIA, Russia, SAUDI ARABIA, Singapore, SLOVAKIA, SOUTH AFRICA, SPAIN, SRI LANKA, SWEDEN, SWITZERLAND, SYRIA, TAIWAN, TAJIKISTAN, Thailand, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, VENEZUELA, Viet Nam, YUGOSLAVIA.

Lot / Code Information

1. Product Code: 3F, No UDI Number, Serial Numbers: M13F1043G, B23F1531G, B23F1532G, B23F2216G, A23F1290G, B23F1324G, M13F1152G, M13F1153G, M13F1154G, M13F1155G, M13F1164G, M13F1165G, M13F1166G, M13F1168G, M13F1169G, L13F0687G, D23F1925G, D23F1968G, E23F2074G, E23F2075G, B23F1402G, M13F1059G, M13F1173G, M13F1109G, C23F1815G, A23F1260G, J13F0272G, C23F1607G, D23F1981G, M13F0968G, L13F0683G, L13F0576G, J13F0274G, B23F1302G, K13F0437G, C23F1793G, D23F1943G, M13F1094G, B23F1495G, K13F0481G, L13F0571G, B23F1304G, C23F1808G, D23F1899G, M13F1151G, J13F0098G, J13F0099G, J13F0100G, C23F1594G, M13F1099G, B23F1439G, J13F0229G, L13F0600G, K13F0499G, K13F0500G, K13F0501G, L13F0623G, L13F0624G, L13F0625G, B23F13886, B23F1388G, B23F1390G, D23F1851G, D23F1861G, J13F0369G, M13F1075G, M13F1084G, M13F0891G, M13F0892G, A23F1229G, E23F2036G, L13F0776G, A23F1258G, B23F1315G, B23F1496G, B23F1501G, B23F1502G, B23F1506G, B23F1508G, C23F1784G, F13F0006G, J13F0006G, L13F0864G, L13F0865G, L13F0866G, L13F0668G, 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L13F0816G, C23F16549, D23F1963G, A23F1205G, J13F0174G, C23F1639G; 2. Product Code: 4T, UDI Number (Serial Numbers): Not Applicable (F24T0254G), Not Applicable (F24T0259G), Not Applicable (F24T0264G), Not Applicable (F24T0279G), Not Applicable (A44T4691G), Not Applicable (A44T4713G), Not Applicable (C44T4931G), Not Applicable (D34T2574G), Not Applicable (H34T3263G), Not Applicable (H34T3264G), Not Applicable (H34T3266G), Not Applicable (H34T3267G), Not Applicable (H34T3268G), Not Applicable (H34T3270G), Not Applicable (H34T3272G), Not Applicable (H34T3274G), Not Applicable (M24T1660G), Not Applicable (M24T1661G), Not Applicable (M24T1662G), Not Applicable (M24T1672G), Not Applicable (M24T1710G), Not Applicable (M24T1716G), Not Applicable (M24T1718G), Not Applicable (M24T1721G), Not Applicable (M34T4314G), Not Applicable (M34T4315G), Not Applicable (M34T4316G), Not Applicable (M34T4321G), Not Applicable (M34T4360G), Not Applicable (M34T4368G), Not Applicable (M34T4482G), Not Applicable (M34T4215G), Not Applicable (M34T4216G), Not Applicable (J34T3725G), Not Applicable (J34T3752G), Not Applicable (J34T3755G), Not Applicable (M34T4340G), Not Applicable (G24T0384G), Not Applicable (K24T1151G), Not Applicable (L24T1274G), Not Applicable (L24T1284G), Not Applicable (L24T1377G), Not Applicable (L24T1401G), Not Applicable (L34T4001G), Not Applicable (A44T4739G), Not Applicable (G24T0475G), Not Applicable (A44T4573G), Not Applicable (C34T2261G), Not Applicable (B44T4778G), Not Applicable (F24T0081G), Not Applicable (F24T0292G), Not Applicable (F24T0294G), Not Applicable (F24T0296G), Not Applicable (F24T0297G), Not Applicable (F24T0318G), Not Applicable (F34T2928G), Not Applicable (K24T1003G), Not Applicable (L34T4174G), Not Applicable (F34T3021G), Not Applicable (C34T2336G), Not Applicable (F24T0242G), Not Applicable (L34T4041G), Not Applicable (M34T4479G), Not Applicable (F24T0084G), Not Applicable (G24T0564G), Not Applicable (M24T1736G), Not Applicable (M34T4449G), Not Applicable (M34T4450G), Not Applicable (B34T1952G), Not Applicable (A34T1762G), Not Applicable (F24T0124G), Not Applicable (F24T0241G), Not Applicable (F34T2959G), Not Applicable (J24T0609G), Not Applicable (J24T0826G), Not Applicable (K24T1143G), Not Applicable (K34T3974G), Not Applicable (M34T4381G), Not Applicable (A34T1853G), Not Applicable (B44T4800G), Not Applicable (D44T5014G), Not Applicable (K34T3833G), Not Applicable (K34T3834G), Not Applicable (K34T3837G), Not Applicable (K34T3843G), Not Applicable (K34T3858G), Not Applicable (K34T3859G), Not Applicable (K34T3966G), Not Applicable (M24T1560G), Not Applicable (M24T1665G), Not Applicable (M24T1673G), Not Applicable (M24T1692G), Not Applicable (M34T4413G), Not Applicable (M34T4415G), Not Applicable (M34T4442G), Not Applicable (M34T4443G), Not Applicable (M34T4444G), Not Applicable (M34T4445G), Not Applicable (L34T4036G), Not Applicable (C34T2256G), Not Applicable (K24T1165G), Not Applicable (L24T1309G), Not Applicable (M24T1528G), Not Applicable (C34T2324G), Not Applicable (C34T2326G), Not Applicable (C34T2328G), Not Applicable (C34T2341G), Not Applicable (A34T1825G), Not Applicable (A34T1826G), Not Applicable (A34T1827G), Not Applicable (A34T1829G), Not Applicable (A34T1830G), Not Applicable (A34T1831G), Not Applicable (A34T1832G), Not Applicable (A34T1848G), Not Applicable (A34T1896G), Not Applicable (A34T1899G), Not Applicable (A34T1900G), Not Applicable (A34T1903G), Not Applicable (B34T2033G), Not Applicable (C34T2298G), Not Applicable (C44T4984G), Not Applicable (G24T0512G), Not Applicable (J34T3789G), Not Applicable (J34T3791G), Not Applicable (C34T2275G), Not Applicable (C34T2361G), Not Applicable (C34T2365G), Not Applicable (C34T2378G), Not Applicable (F24T0247G), Not Applicable (J24T0867G), Not Applicable (J24T0873G), Not Applicable (J34T3597G), Not Applicable (J34T3598G), Not Applicable (J34T3604G), Not Applicable (J34T3605G), Not Applicable (J34T3606G), Not Applicable (J34T3628G), Not Applicable (J34T3631G), Not Applicable (J34T3669G), Not Applicable (K34T3871G), Not Applicable (F34T2927G), Not Applicable (M24T1608G), Not Applicable (M24T1647G), Not Applicable (D34T2530G), Not Applicable (D34T2534G), Not Applicable (D34T2538G), Not Applicable (J34T3517G), Not Applicable (J24T0831G), Not Applicable (C34T2265G), Not Applicable (C34T2267G), Not Applicable (F24T0269G), Not Applicable (J34T3816G), Not Applicable (B34T1947G), Not Applicable (B34T1951G), Not Applicable (J24T0846G), Not Applicable (J24T0862G), Not Applicable (J24T0876G), Not Applicable (H34T3437G), Not Applicable (A44T4581G), Not Applicable (B34T1984G), Not Applicable (B34T1989G), Not Applicable (B44T4905G), Not Applicable (B44T4913G), Not Applicable (C44T4930G), Not Applicable (F24T0054G), Not Applicable (F24T0239G), Not Applicable (G24T0414G), Not Applicable (G24T0506G), Not Applicable (G24T0520G), Not Applicable (G24T0521G), Not Applicable (G24T0524G), Not Applicable (H34T3284G), Not Applicable (J24T0738G), Not Applicable (J24T0833G), Not Applicable (J24T0836G), Not Applicable (M24T1668G), Not Applicable (M24T1671G), Not Applicable (D34T2454G), Not Applicable (D34T2535G), Not Applicable (D34T2545G), Not Applicable (F24T0053G), Not Applicable (D44T5027G), Not Applicable (K24T1117G), Not Applicable (K24T1118G), Not Applicable (K24T1190G), Not Applicable (K24T1191G), Not Applicable (K24T1196G), Not Applicable (K24T1197G), Not Applicable (K24T1200G), Not Applicable (B44T4880G), Not Applicable (B44T4882G), Not Applicable (J24T0642G), Not Applicable (J24T0813G), Not Applicable (M24T1569G), Not Applicable (B34T2021G), Not Applicable (M24T1540G), Not Applicable (J34T3601G), Not Applicable (M24T1603G), Not Applicable (M24T1749G), Not Applicable (M34T4339G), Not Applicable (M34T4493G), Not Applicable (M34T4494G), Not Applicable (K34T3968G), Not Applicable (D34T2629G), Not Applicable (B34T2006G), Not Applicable (M24T1609G), Not Applicable (M24T1663G), Not Applicable (A44T4676G), Not Applicable (B34T1991G), Not Applicable (B34T1998G), Not Applicable (B34T1999G), Not Applicable (B34T2105G), Not Applicable (B34T2107G), Not Applicable (B34T2108G), Not Applicable (B34T2109G), Not Applicable (D34T2440G), Not Applicable (H34T3419G), Not Applicable (J24T0704G), Not Applicable (J24T0790G), Not Applicable (J24T0792G), Not Applicable (J24T0799G), Not Applicable (J24T0854G), Not Applicable (J34T3807G), Not Applicable (K34T3839G), Not Applicable (K34T3840G), Not Applicable (K34T3841G), Not Applicable (K34T3844G), Not Applicable (L24T1304G), Not Applicable (F34T3027G), Not Applicable (K34T3920G), Not Applicable (L34T4102G), Not Applicable (L34T4103G), Not Applicable (L34T4104G), Not Applicable (L34T4105G), Not Applicable (L34T4106G), Not Applicable (K24T1214G), Not Applicable (K24T1215G), Not Applicable (K24T1225G), Not Applicable (L24T1362G), Not Applicable (H34T3477G), Not Applicable (K24T1266G), Not Applicable (L34T4005G), Not Applicable (M24T1455G), Not Applicable (F34T2841G), Not Applicable (M34T4432G), Not Applicable (F24T0308G), Not Applicable (F24T0309G), Not Applicable (G24T0417G), Not Applicable (G24T0420G), Not Applicable (J34T3521G), Not Applicable (G24T0462G), Not Applicable (G24T0470G), Not Applicable (B34T1979G), Not Applicable (B34T1986G), Not Applicable (B34T1987G), Not Applicable (L24T1294G), Not Applicable (L24T1303G), Not Applicable (L24T1315G), Not Applicable (H34T3361G), Not Applicable (K24T1193G), Not Applicable (K24T1198G), Not Applicable (B34T2043G), Not Applicable (B34T2047G), Not Applicable (B34T2055G), Not Applicable (B34T2202G), Not Applicable (L24T1391G), Not Applicable (F24T0278G), Not Applicable (F24T0149G), Not Applicable (F24T0211G), Not Applicable (G24T0324G), Not Applicable (H34T3435G), Not Applicable (M24T1512G), Not Applicable (J24T0900G), Not Applicable (L34T4109G), Not Applicable (M34T4446G), Not Applicable (M34T4481G), Not Applicable (M34T4539G), Not Applicable (H34T3441G), Not Applicable (K34T3978G), Not Applicable (B44T4781G), Not Applicable (F34T2978G), Not Applicable (B44T4745G), Not Applicable (B44T4751G), Not Applicable (D34T2470G), Not Applicable (K24T1184G), Not Applicable (A34T1781G), Not Applicable (A34T1784G), Not Applicable (A34T1785G), Not Applicable (A34T1789G), Not Applicable (A34T1791G), Not Applicable (C34T2407G), Not Applicable (J24T0823G), Not Applicable (D34T2509G), Not Applicable (K34T3886G), Not Applicable (K34T3928G), Not Applicable (K34T3960G), Not Applicable (F24T0276G), Not Applicable (B34T2163G), Not Applicable (B44T4783G), Not Applicable (C34T2235G), Not Applicable (F24T0256G), Not Applicable (J24T0671G), Not Applicable (J24T0700G), Not Applicable (J24T0879G), Not Applicable (J24T0884G), Not Applicable (J34T3686G), Not Applicable (J34T3688G), Not Applicable (J34T3689G), Not Applicable (J34T3693G), Not Applicable (K34T3900G), Not Applicable (K34T3902G), Not Applicable (A44T4704G), Not Applicable (A44T4707G), Not Applicable (K24T1033G), Not Applicable (K24T1039G), Not Applicable (A44T4637G), Not Applicable (A44T4639G), Not Applicable (B44T4747G), Not Applicable (F24T0203G), Not Applicable (G34T3207G), Not Applicable (B34T2019G), Not Applicable (D34T2473G), Not Applicable (D34T2475G), Not Applicable (D34T2491G), Not Applicable (D34T2493G), Not Applicable (D34T2495G), Not Applicable (D34T2518G), Not Applicable (D34T2527G), Not Applicable (D34T2541G), Not Applicable (D34T2546G), Not Applicable (D34T2570G), Not Applicable (D34T2602G), Not Applicable (D34T2604G), Not Applicable (D34T2605G), Not Applicable (D34T2606G), Not Applicable (M34T4318G), Not Applicable (M24T1600G), Not Applicable (M24T1700G), Not Applicable (D34T2482G), Not Applicable (D34T2516G), Not Applicable (D34T2573G), Not Applicable (F34T2854G), Not Applicable (F34T2858G), Not Applicable (F34T2863G), Not Applicable (F34T2864G), Not Applicable (F34T2865G), Not Applicable (F34T2867G), Not Applicable (G24T0448G), Not Applicable (K24T1231G), Not Applicable (K24T1239G), Not Applicable (M24T1677G), Not Applicable (M24T1687G), Not Applicable (M24T1706G), Not Applicable (M24T1712G), Not Applicable (C34T2351G), Not Applicable (C34T2372G), Not Applicable (J34T3653G), Not Applicable (H34T3486G), Not Applicable (J34T3681G), Not Applicable (E34T2726G), Not Applicable (E34T2727G), Not Applicable (E34T2729G), Not Applicable (E34T2732G), Not Applicable (E34T2737G), Not Applicable (F24T0288G), Not Applicable (F24T0289G), Not Applicable (F24T0290G), Not Applicable (F24T0291G), Not Applicable (M24T1504G), Not Applicable (M24T1511G), Not Applicable (M24T1555G), Not Applicable (M24T1561G), Not Applicable (M34T4390G), Not Applicable (B44T4909G), Not Applicable (G24T0543G), Not Applicable (G24T0545G), Not Applicable (H24T0594G), Not Applicable (H34T3265G), Not Applicable (A34T1803G), Not Applicable (F24T0271G), Not Applicable (F24T0284G), Not Applicable (F24T0285G), Not Applicable (F24T0298G), Not Applicable (F24T0299G), Not Applicable (F24T0300G), Not Applicable (F24T0301G), Not Applicable (F24T0303G), Not Applicable (F24T0316G), Not Applicable (G24T0484G), Not Applicable (G24T0488G), Not Applicable (G24T0490G), Not Applicable (G24T0499G), Not Applicable (G24T0542G), Not Applicable (J24T0692G), Not Applicable (J24T0709G), Not Applicable (J24T0710G), Not Applicable (J24T0711G), Not Applicable (J24T0712G), Not Applicable (J24T0716G), Not Applicable (J24T0717G), Not Applicable (J24T0718G), Not Applicable (J24T0722G), Not Applicable (J24T0830G), Not Applicable (K24T1004G), Not Applicable (K24T1014G), Not Applicable (K24T1080G), Not Applicable (F24T0236G), Not Applicable (G24T0411G), Not Applicable (B44T4904G), Not Applicable (F24T0130G), Not Applicable (F24T0272G), Not Applicable (F24T0273G), Not Applicable (G24T0529G), Not Applicable (G24T0538G), Not Applicable (J24T0630G), Not Applicable (J24T0651G), Not Applicable (J24T0691G), Not Applicable (J24T0721G), Not Applicable (J24T0723G), Not Applicable (K24T1007G), Not Applicable (K24T1116G), Not Applicable (K24T1119G), Not Applicable (K24T1120G), Not Applicable (K24T1122G), Not Applicable (K24T1123G), Not Applicable (L24TE1JG), Not Applicable (H34T3277G), Not Applicable (B34T2029G), Not Applicable (B34T2203G), Not Applicable (C34T2268G), Not Applicable (C34T2269G), Not Applicable (C34T2281G), Not Applicable (C34T2397G), Not Applicable (F24T0074G), Not Applicable (F24T0077G), Not Applicable (F24T0078G), Not Applicable (F24T0079G), Not Applicable (G24T0468G), Not Applicable (M24T1442G), Not Applicable (M24T1513G), Not Applicable (M34T4452G), Not Applicable (M34T4453G), Not Applicable (A34T1870G), Not Applicable (B34T1942G), Not Applicable (B34T2111G

Other Recalls from GE Healthcare, LLC

Recall # Classification Product Date
Z-1566-2022 Class II (1) GE Centricity Universal Viewer 6.0, Model 2... Jul 15, 2022
Z-1430-2022 Class II SIGNA Premier magnetic resonance scanner, model... Jun 24, 2022
Z-1466-2022 Class II Centricity PACS Software Version 7.0 SP0.0.4.7 Jun 14, 2022
Z-1333-2022 Class II GE Centricity Universal Viewer Zero Footprint. ... Jun 8, 2022
Z-1511-2022 Class II Service manuals for the CT, PET, or NM table as... Jun 2, 2022

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.