Table Patient Step on RFX/SFX, Legacy, and Precision 500D systems
FDA Device Recall #Z-2179-2017 — Class II — February 6, 2017
Recall Summary
| Recall Number | Z-2179-2017 |
| Classification | Class II — Moderate risk |
| Date Initiated | February 6, 2017 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | GE Healthcare, LLC |
| Location | Waukesha, WI |
| Product Type | Devices |
| Quantity | 2,380 (2,215 US; 165 OUS) |
Product Description
Table Patient Step on RFX/SFX, Legacy, and Precision 500D systems
Reason for Recall
Reported incidents of a patient step detaching from the table. A fall from a patient step detaching while in use could result in an injury to a patient or operator.
Distribution Pattern
US: Nationwide including DC and Puerto Rico. OUS: Argentina, Australia, Brazil, Canada, Chile, Colombia, Costa Rica, Egypt, France, Germany, Greece, Honduras, Hungary, Indonesia, Ireland, Israel, Italy, Jamaica, Jordan, Kuwait, Libya, Malaysia, Malta, Mexico, Panama, Portugal, Russia, Saudi Arabia, Saudi Arabia, Slovakia, Spain, Thailand, United Arab Emirates, United Kingdom, Vietnam.
Lot / Code Information
FMI 10908 Initial Consignee List Mfg. 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318448CRM1 00000135915DP7 318473RD1 00000008860M39 318473RD4 00001017448WK0 225755RF2 30501M31 225761PRE500 00001031837WK6 225924WRF2 00000030501M31 AM14BIM496 Not Available 318346RD1 00000025397M31 985867RF3 00000981584WK6 985875P500 00000010739M31 337457MRF 00000008858M33 337531FRM4 00001024743WK5 225NORF 00000989786WK9 985230DCRF3 00000989096WK3 985230DCRF4 00000008961M35 985230RF5 00000030337M30 985230RF6 00000014273M37 318927RF1 00001027482WK7 504873TR4P 00000983225WK4 504873TR5P 00000024861M37 985LCFB 00000003583M32 504842ENDO 00001024575WK1 504842RM3 00000997104WK5 337261URF1 00000117092DP7 337521RF1 00000004529M34 337521RF2 00000005998M30 225869P500 00001024741WK9 504837P500 12084 318371P500 00000012922M31 318330RF1 00000004648M32 318330RF2 28181M36 318812RF 00000010219M34 504380P500 00000005941M30 504894RF 00000011182M33 504897P513 00000003575M38 504988ENDO 00001023632WK1 504988P500 Not Available 504CMP500 00000031054M30 504CRHP500 Not Available 2978112 Not Available 2978110 1035409WK0 985646NSRF3 00001025258WK3 985646RF4 00000978076WK8 504447P500 Not Available 985447P500 00001001071WK8 337363VRF1 00001031848WK3 225658RF1 00000981583WK8 617636RMD 00000006152M33 617667ERCP1 00000006335M34 617667ERCP2 00000012773M38 617724ENDO 00000984287WK3 617726PR35A 00000992390WK5 617726PR64A 00000995344WK9 617732ENDO 00000984285WK7 617732P15 00000981789WK1 617732P16 00000002779M37 617789RFE 00000011843M30 781895RF1WA 00000005154M30 508941RM5 00000979919WK8 781744RF3 00000989779WK4 617726PR32A 00000002978M35 508457RF3 00000980118WK4 978521MVRF4 00000013129M32 781477RF2 00000020626M38 781306RF1 00000011194M38 781979RF1 00001021880WK8 508693MVXF 00000008138M30 413447BRF1 00000995872WK9 413447BRF2 00000013664M38 413854P500 00000022652M32 978741SRF3 00000979921WK4 978741SRF9 1026264WK0 781624HSSHFP 00001026264WK0 781624HSSHRF 00000001427M35 413748RF2 00000009122M33 413748RM3 00001006188WK5 781756BPRF1A 00001026636WK9 508793MP500 00000004530M32 508856EN1 00000017485M34 508856ORP500 00000017783M32 978368P500 00000997114WK4 443481RF4 00000024278M34 443481SJKP500 00000023220M37 UICGERF1 00001003072WK4 410225RF3 1034359WK8 RADNETRF1298 00000030497M32 RADNETRF1303 Not Available RADNETRF1303FP1 00000981069WK8 301896RF2 00001022261WK0 301295P500 00000020788M36 301295P500A 29112M30 RADNETRF1301 00001014111WK7 410604KIRF 00000013830M35 301877RF2 00000982893WK0 301877RF8 00001028432WK1 RADNETRF1286 00000100539WK2 301292P500 00000020302M36 240566DF1 00001029139WK1 240566RHRF1 2088836 240566RHRF2 00001025006WK6 RADNETRF1268 MISSING_SN_GON4225310 RADNETRF1297 Not Available RADNETRF1296 00000989778WK6 301714RF2 00001026786WK2 301609P500A 00000006329M37 301475P500A 00001025008WK2 RADNETRF1269 00000011756M34 410535P500A 00000017941M36 301765P500 00001030123WK2 301891P500 00001034585WK8 RADNETRF1299 00000026412M37 RADNETRF1295 00001036558WK3 AM13XJ54 29262M33 RADNETRF1302 00000011725M39 207973P500D 00001005334WK6 207454RF1 00000022650M36 207498P500 00001025050WK4 207564P500 00000008600M39 207553P500 00000029356M33 207879P500 00001028999WK9 517543P500D 00001034584WK1 586263P500 00000997659WK8 313593P500 00000008041M36 313576P500A 00000009872M33 248615P500E 00000010377M30 810762P500 00001027592WK3 989246P500 28947M30 810606RF1 00000014476M36 616267P500A 00000119459DP6 616267P500B 00000979619WK4 616391PRECISION 00000022407M31 231225P500 00001030299WK0 269945P500 00000005419M37 517437FL 00000008473M31 906485P500 00000017013M34 269789P500 00000010811M38 906884P500 00001005386WK6 269657P500D 421798GE0 248652ERCP Not Available 248551P500RM2 00001033791WK3 989497P500 00001030701WK5 269637P500 00000010460M34 734671P500 00000135923DP1 248524P500 00000022906M32 320845P500 00000006504M35 507526P500 00000974342WK8 218736RM4A 00000979780WK4 320693PREC 00000998428WK7 507283P500 00000012606M30 763581P500 00000030498M30 320589P500 00000025725M33 218347P500 00000975908WK5 763520N8 00000008660M33 651430P500 00000001445M36 218741P500 00000996479WK2 WH231P500D 00000079050HL1 WH231WDR2 00000980629WK0 816348BRF1 00000989783WK6 660542P500 00001032085WK1 660707PREC1 00000011195M35 573814VARF1 00001029006WK2 573231HCP500 1020690WK2 816380P500D 00001005380WK9 573359PRF1 00000997873WK5 573486HR1 00001006202WK4 816501RF1 00000003980M30 816501RF2 00000004240M38 816501RF3 1033965WK3 573SMHP500 00001032084WK4 417347FEP500 00001026972WK8 417347P500 00001034588WK2 816276RMCRF2 1035015WK5 816478P500D 00000005337M31 417682BRF 1035223
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.