CLASS II Device recall · Reported 30 Sep 2020 · FDA Enforcement Report
NM/CT 870 DR recalled by GE Healthcare
GE Healthcare is recalling NM/CT 870 DR, 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-2998-2020
- 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
NM/CT 870 DR Model # H3100AS
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
Is NM/CT 870 DR recalled?
Yes. GE Healthcare recalled NM/CT 870 DR on 14 Aug 2020. The recall is Class II and its status is Terminated. Recall number Z-2998-2020.
Why was it recalled?
Rotor bearing screws were found loose on detector.
Which lots are affected?
Serial # 870X64001 System ID: 030020NU06 Serial # 870X64004 System ID: M4018555 Serial # 870X64012 System ID: X634445001 Serial # 870X64007 System ID: V2728113 Serial # 870X64009 System ID: M4016255 Serial # 870X64026 System ID: M40230109 Serial # 870X64017 System ID: M40240121 Serial # 870X64018 System ID:M40240121 Serial # 870X64015 System ID:M40345223 Serial # 870X64016 System ID:499221NU01 Serial # 870X64031 System ID:083049209623319 Serial # 870X64014 System ID:IL1028NM41 Serial # 870X64022 System ID: A5173220 Serial # 870X64019 System ID: 0850260167XE6 Serial # 870X64020 System ID: 0850260169 Serial # 870X64025 System ID: EMM0135 Serial # 870X64010 System ID:NM2882PA Serial # 870X64027 System ID: PL0398NM01 Serial # 870X64029 System ID: PL1031NM01 Serial # 870X64030 System ID: PL2190NM01 Serial # 870X64028 System ID: PL0372NM01 Serial # 870X64023 System ID: 600042NM10 Serial # 870X64013 System ID: NP473631 Serial # 870X64021 System ID: G001NU12 Serial # 870X64008 System ID:00669NUC03
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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