CLASS II Device recall · Reported 21 Jan 2015 · FDA Enforcement Report

Revolution CT., multi-slice (256 detector row) CT scanner recalled

GE Healthcare is recalling GE Healthcare Revolution CT., multi-slice (256 detector row) CT scanner, distributed in California, Florida, Illinois, New York, Utah, Washington. The recall was initiated on 19 Dec 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesMfg Lot or Serial # System ID 00000437461CN7 519646REVO1 00000437837CN8 M2322254 00000438342CN8 828210096 00000437028CN4 REV001 00000438864CN1 900010CT06 00000439199CN1 260010CT19 00000439068CN8 AE1477CT01 00000437787CN5 786596WKRIVO 00000438503CN5 206598REV1 00000438951CN6 309655REVCT 00000439029CN0 801662REV1 00000439160CN3 212241REVCT 00000439367CN4 415476MCT3

Quantity recalled13 (7 US, 6 OUS)

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-0985-2015
FDA event ID: 70074
Recalling firm: GE Healthcare, Waukesha, WI
Classification: Class II
Status: Terminated
Recall initiated: 19 Dec 2014
FDA classified: 15 Jan 2015
Reported: 21 Jan 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Imaging Equipment

Timeline

19 Dec 2014	Recall initiated by company
15 Jan 2015	Classified by FDA	+27 days
21 Jan 2015	Published in enforcement report	+6 days

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

Reason for recall

Potential safety issue due to a required torque check on three bolted joints of the Revolution CT scanner. No injuries or illnesses reported.

Product as listed by the FDA

GE Healthcare Revolution CT., multi-slice (256 detector row) CT scanner.

Where it was distributed

US: FL, WA, IL, UT, NY, CA. OUS: Canada, France, Hong Kong, Japan, Switzerland, United Arab Emirates.

California Florida Illinois New York Utah Washington

Questions about this recall

Is Revolution CT., multi-slice (256 detector row) CT scanner recalled?

Yes. GE Healthcare recalled Revolution CT., multi-slice (256 detector row) CT scanner on 19 Dec 2014. The recall is Class II and its status is Terminated. Recall number Z-0985-2015.

Why was it recalled?

Potential safety issue due to a required torque check on three bolted joints of the Revolution CT scanner. No injuries or illnesses reported.

Which lots are affected?

Mfg Lot or Serial # System ID 00000437461CN7 519646REVO1 00000437837CN8 M2322254 00000438342CN8 828210096 00000437028CN4 REV001 00000438864CN1 900010CT06 00000439199CN1 260010CT19 00000439068CN8 AE1477CT01 00000437787CN5 786596WKRIVO 00000438503CN5 206598REV1 00000438951CN6 309655REVCT 00000439029CN0 801662REV1 00000439160CN3 212241REVCT 00000439367CN4 415476MCT3

Where was it sold?

US: FL, WA, IL, UT, NY, CA. OUS: Canada, France, Hong Kong, Japan, Switzerland, United Arab Emirates.

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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