CLASS II ONGOING Device recall · Reported 19 May 2021 · FDA Enforcement Report

NM/CT 850 Nuclear Medicine / CT Scanners recalled by GE Healthcare

GE Healthcare is recalling NM/CT 850 Nuclear Medicine / CT Scanners, distributed nationwide in the US. The recall was initiated on 7 Feb 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesGTIN*00840682140775

Quantity recalled242 in total (17 units US)

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-1545-2021
FDA event ID: 87811
Recalling firm: GE Healthcare, Waukesha, WI
Classification: Class II
Status: Ongoing
Recall initiated: 7 Feb 2021
FDA classified: 11 May 2021
Reported: 19 May 2021
Type: FDA Mandated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Imaging Equipment

Timeline

7 Feb 2021	Recall initiated by company
11 May 2021	Classified by FDA	+93 days
19 May 2021	Published in enforcement report	+8 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 of a potential issue on 800 family NM/CT Scanners that could cause a shift in CT radiation exposure range of up to 5cm compared to the intended radiation exposure range of the planned scan under specific workflows. The issue occurs only on a hybrid whole-body continuous F3 protocol with Zoom < 1 where the scan range is set on the Smart Console. In some cases, this may also necessitate a re-scan of the patient, which would expose the patient to additional X-ray radiation.

Product as listed by the FDA

NM/CT 850 Nuclear Medicine / CT Scanners

Where it was distributed

Worldwide distribution - US Nationwide

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

GTIN*00840682140775

Where was it sold?

Worldwide distribution - US Nationwide

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

2 other products · FDA event 87811

This product is part of a recall event; the main page for the event is NM/CT 860 Nuclear Medicine / CT Scanners recalled by GE Healthcare.

Reported	Class	Recall	Company	Reason	Where
19 May 2021	CLASS II	NM/CT 860 Nuclear Medicine / CT Scanners recalled by GE Healthcare	GE Healthcare	Other	Nationwide
19 May 2021	CLASS II	NM/CT 870 DR Nuclear Medicine / CT Scanners recalled by GE Healthcare	GE Healthcare	Other	Nationwide

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