Discovery NM 630 Model # H3101RH
FDA Device Recall #Z-2994-2020 — Class II — August 14, 2020
Recall Summary
| Recall Number | Z-2994-2020 |
| Classification | Class II — Moderate risk |
| Date Initiated | August 14, 2020 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | GE Healthcare, LLC |
| Location | Waukesha, WI |
| Product Type | Devices |
| Quantity | 62 units |
Product Description
Discovery NM 630 Model # H3101RH
Reason for Recall
Rotor bearing screws were found loose on detector.
Distribution Pattern
USA : AR CT FL GA IL KS KY LA MA MD MI MN MO NE NJ NV NY OH OK RI SC TN TX VA VT WA WI OUS: ARGENTINA AUSTRIA BELGIUM BRAZIL Canada CHINA FRANCE GERMANY GREECE INDIA ISRAEL ITALY JAPAN Korea (Republic of) NETHERLANDS NORWAY PANAMA POLAND PORTUGAL Russia SPAIN SWEDEN SWITZERLAND TAIWAN THAILAND TURKEY UNITED KINGDOM VIETNAM
Lot / Code Information
Serial # 63GX50024 System ID: 501450D630 Serial # 63GX50001 System ID: 863494NM Serial # 63GX50037 System ID: 3v05223D630A Serial # 63GX50060 System ID: 305223D630B Serial # 63GX50017 Not Available Serial # 63GX50034 System ID: 478289DIS Serial # 63GX50040 System ID: 0004624609 Serial # 63GX50014 System ID: 618998NM Serial # 63GX50019 System ID: 270745NM1 Serial # 63GX50016 System ID: Not Available Serial # 63GX50022 System ID: 906225CARDNM1 Serial # 63GX50021 System ID: 906225CARDNM2 Serial # 63GX50018 System ID: 269637NM630 Serial # 63GX50009 System ID: NM555658 Serial # 63GX50031 System ID: Not Available Serial # 63GX50020 System ID: 402481D630C Serial # 63GX50054 System ID: 973450D630 Serial # 63GX50008 System ID: 856641NM Serial # 63GX50061 System ID: 702962NM1 Serial # 63GX50062 System ID: 702724NM1 Serial # 63GX50050 System ID: 702388DISC Serial # 63GX50043 Not Available Serial # 63GX50032 System ID: 513861NM Serial # 63GX50055 System ID: 513861NM1 Serial # 63GX50013 System ID: 740MGD630 Serial # 63GX50047 System ID: 440743D630 Serial # 63GX50002 System ID: 419251NM Serial # 63GX50025 System ID: 330841DISCNM Serial # 63GX50033 System ID: 330841DISCNM2 Serial # 63GX50038 System ID: 918756D630 Serial # 63GX50044 System ID: 803865D630 Serial # 63GX50035 Not Available Serial # 63GX50005 System ID: 713440NM630B Serial # 63GX50029 System ID: 281MHNE630 Serial # 63GX50012 System ID: 832505D630 Serial # 63GX50046 System ID: 210351NM Serial # 63GX50039 System ID: 281MWL630A Serial # 63GX50049 System ID: 281MWL630B Serial # 63GX50011 System ID: LGMONT630 Serial # 63GX50030 System ID: 434243DIS Serial # 63GX50052 System ID: NM5892AR Serial # 63GX50051 System ID: NM2009AR Serial # 63GX50015 System ID: NM63GX50015 Serial # 63GX50027 System ID: NM63GX50027 Serial # 63GX50036 System ID: NM63GX50036 Serial # 63GX50006 System ID: NM63GX50006 Serial # 63GX50007 System ID: NM63GX50007 Serial # 63GX50010 System ID: NM63GX50010 Serial # 63GX50026 System ID: NM63GX50026XE Serial # 63GX50057 System ID: 082426190035 Serial # 63GX50045 System ID: 082426090053 Serial # 63GX50023 System ID: 403438NU01 Serial # 63GX50048 System ID: 418404NU02 Serial # 63GX50041 System ID: 083026202460918 Serial # 63GX50003 System ID: 083026860786218 Serial # 63GX50028 System ID: 083026806403618 Serial # 63GX50058 System ID: 083026803079619 Serial # 63GX50042 System ID: 0853260185 Serial # 63GX50053 System ID: 1573MI0011 Serial # 63GX50004 System ID: 06184NUC05 Serial # 63GX50056 System ID: 5973MI0019 Serial # 63GX50059 System ID: 5973MI0018
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.