CLASS II Device recall · Reported 20 Jan 2021 · FDA Enforcement Report

GE NM/CT 850 system recalled by GE Healthcare

GE Healthcare is recalling GE NM/CT 850 system. The recall was initiated on 10 Dec 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial numbers: 85EY67048, 850Y61018, 85EY67045, 85EY67046, 85EY67047, 850Z61038, 85EY67043, 850Z61042, 85EZ67056, 850Z61043, 850Z61044, 850Z61045, 850Z61041, 850Z61039, 850Z61040, 85EZ67055, 85EZ67053, 85EZ67054, 850Y61019, 85EY67044, 85EY67049, 85EZ67052, 85EY67050, 85EZ67051

Quantity recalled24 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-0853-2021
FDA event ID: 87023
Recalling firm: GE Healthcare, Waukesha, WI
Classification: Class II
Status: Terminated
Recall initiated: 10 Dec 2020
FDA classified: 13 Jan 2021
Reported: 20 Jan 2021
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Imaging Equipment

Timeline

10 Dec 2020	Recall initiated by company
13 Jan 2021	Classified by FDA	+34 days
20 Jan 2021	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

GE Healthcare has become aware that rotor bearing screws were found loose on one detector in the field, leading to the release of one of the four rotor bearings in the detector.

Product as listed by the FDA

GE NM/CT 850 system Model Number H3907AD - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body.

Where it was distributed

Worldwide

Questions about this recall

Is GE NM/CT 850 system recalled?

Yes. GE Healthcare recalled GE NM/CT 850 system on 10 Dec 2020. The recall is Class II and its status is Terminated. Recall number Z-0853-2021.

Why was it recalled?

GE Healthcare has become aware that rotor bearing screws were found loose on one detector in the field, leading to the release of one of the four rotor bearings in the detector.

Which lots are affected?

Serial numbers: 85EY67048, 850Y61018, 85EY67045, 85EY67046, 85EY67047, 850Z61038, 85EY67043, 850Z61042, 85EZ67056, 850Z61043, 850Z61044, 850Z61045, 850Z61041, 850Z61039, 850Z61040, 85EZ67055, 85EZ67053, 85EZ67054, 850Y61019, 85EY67044, 85EY67049, 85EZ67052, 85EY67050, 85EZ67051

Where was it sold?

Worldwide

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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