CLASS II Device recall · Reported 30 Sep 2020 · FDA Enforcement Report
Discovery NM recalled by GE Healthcare
GE Healthcare is recalling Discovery NM 630, distributed in 25 states. The recall was initiated on 14 Aug 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2994-2020
- FDA event ID
- 86337
- Recalling firm
- GE Healthcare, Waukesha, WI
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 14 Aug 2020
- FDA classified
- 21 Sep 2020
- Reported
- 30 Sep 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 14 Aug 2020 | Recall initiated by company | |
| 21 Sep 2020 | Classified by FDA | +38 days |
| 30 Sep 2020 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Rotor bearing screws were found loose on detector.
Product as listed by the FDA
Discovery NM 630 Model # H3101RH
Where it was distributed
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
ArkansasConnecticutFloridaGeorgiaIllinoisKansasKentuckyLouisianaMassachusettsMarylandMichiganMinnesotaMissouriNebraskaNew JerseyNevadaNew YorkRhode IslandSouth CarolinaTennessee
Questions about this recall
Why was it recalled?
Rotor bearing screws were found loose on detector.
Which lots are affected?
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
Where was it sold?
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
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
7 other products · FDA event 86337This product is part of a recall event; the main page for the event is NM/CT recalled by GE Healthcare.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | NM/CT recalled by GE Healthcare | GE Healthcare | Other | 25 states | |
| CLASS II | Discovery NM670 Pro recalled by GE Healthcare | GE Healthcare | Other | 25 states | |
| CLASS II | NM/CT 870 DR recalled by GE Healthcare | GE Healthcare | Other | 25 states | |
| CLASS II | Nm/CT 870 Czt recalled by GE Healthcare | GE Healthcare | Other | 25 states | |
| CLASS II | NM 830 Model # H3910AC recalled by GE Healthcare | GE Healthcare | Other | 25 states | |
| CLASS II | Discovery 670 DR recalled by GE Healthcare | GE Healthcare | Other | 25 states | |
| CLASS II | Nm/CT 860, Spect/CT recalled by GE Healthcare | GE Healthcare | Other | 25 states |
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