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

Nm/CT 860, Spect/CT recalled by GE Healthcare

GE Healthcare is recalling Nm/CT 860, Spect/CT, 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 # 850X61003 , System ID: 401793860NM, Model # H3908AD Serial # 860X62001 , System ID:E6843969, Model # H3908AE Serial # 870X64005 , System ID:HC4387NU05, Model # H3100AS Serial # 860X62002 , System ID:PL0399NM01, Model # H3100AS

Quantity recalled4 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-2992-2020
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 860, SPECT/CT

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 860, Spect/CT recalled?

Yes. GE Healthcare recalled Nm/CT 860, Spect/CT on 14 Aug 2020. The recall is Class II and its status is Terminated. Recall number Z-2992-2020.

Why was it recalled?

Rotor bearing screws were found loose on detector.

Which lots are affected?

Serial # 850X61003 , System ID: 401793860NM, Model # H3908AD Serial # 860X62001 , System ID:E6843969, Model # H3908AE Serial # 870X64005 , System ID:HC4387NU05, Model # H3100AS Serial # 860X62002 , System ID:PL0399NM01, Model # H3100AS

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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