CLASS II Device recall · Reported 30 Sep 2020 · FDA Enforcement Report

NM/CT recalled by GE Healthcare

GE Healthcare is recalling NM/CT 850, distributed in 25 states. The recall was initiated on 14 Aug 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial # 85EX67001 System ID: 203789NM850 Serial # 85EX67023 System ID: 813443D850 Serial # 850X61005 System ID: 847618NM850 Serial # 85EX67019 System ID: 773296NM850 Serial # 85EX67021 System ID: 217554NMCT Serial # 85EX67008 System ID: 779696NM850 Serial # 85EY67015 System ID: 504988NM850 Serial # 85EX67017 System ID: 318212NM Serial # 85EX67012 System ID: 781729NM Serial # 85EX67006 System ID: 573814NM2 Serial # 850X61001 System ID: Not Available Serial # 85EX67002 System ID: 419289D850 Serial # 85EX67009 System ID: 513732NM Serial # 85EX67016 System ID: 972969NM Serial # 85EX67004 System ID: 571472NM850 Serial # 85EX67010 System ID: 804289NM850A Serial # 85EX67011 System ID: 804281NM850A Serial # 85EX67005 System ID: 715717NMCT Serial # 85EX67018 System ID: 414219NMCT Serial # 85EX67013 System ID: 920456NM Serial # 850X61004 System ID: 030601NU06 Serial # 85EX67007 System ID: A5116074 Serial # 850X61002 System ID: NS0001 Serial # 85EX67003 System ID: PL1692NM05 Serial # 85EX67014 System ID: PPR59076

Quantity recalled25 units

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-2991-2020
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 850 Model Number: H3907AD

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

Arkansas Connecticut Florida Georgia Illinois Kansas Kentucky Louisiana Massachusetts Maryland Michigan Minnesota Missouri Nebraska New Jersey Nevada New York Rhode Island South Carolina Tennessee

Questions about this recall

Is NM/CT 850 recalled?

Yes. GE Healthcare recalled NM/CT 850 on 14 Aug 2020. The recall is Class II and its status is Terminated. Recall number Z-2991-2020.

Why was it recalled?

Rotor bearing screws were found loose on detector.

Which lots are affected?

Serial # 85EX67001 System ID: 203789NM850 Serial # 85EX67023 System ID: 813443D850 Serial # 850X61005 System ID: 847618NM850 Serial # 85EX67019 System ID: 773296NM850 Serial # 85EX67021 System ID: 217554NMCT Serial # 85EX67008 System ID: 779696NM850 Serial # 85EY67015 System ID: 504988NM850 Serial # 85EX67017 System ID: 318212NM Serial # 85EX67012 System ID: 781729NM Serial # 85EX67006 System ID: 573814NM2 Serial # 850X61001 System ID: Not Available Serial # 85EX67002 System ID: 419289D850 Serial # 85EX67009 System ID: 513732NM Serial # 85EX67016 System ID: 972969NM Serial # 85EX67004 System ID: 571472NM850 Serial # 85EX67010 System ID: 804289NM850A Serial # 85EX67011 System ID: 804281NM850A Serial # 85EX67005 System ID: 715717NMCT Serial # 85EX67018 System ID: 414219NMCT Serial # 85EX67013 System ID: 920456NM Serial # 850X61004 System ID: 030601NU06 Serial # 85EX67007 System ID: A5116074 Serial # 850X61002 System ID: NS0001 Serial # 85EX67003 System ID: PL1692NM05 Serial # 85EX67014 System ID: PPR59076

Where was it sold?

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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