CLASS II Device recall · Reported 11 May 2016 · FDA Enforcement Report
GE, Revolution CT. The system is intended for head recalled
GE Medical Systems is recalling GE, Revolution CT. The system is intended for head, whole body, cardiac, and vascular, distributed nationwide in the US. The recall was initiated on 20 Apr 2016 and the FDA has classified it as Class II.
Check your package
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-1589-2016
- FDA event ID
- 73974
- Recalling firm
- GE Medical Systems, Waukesha, WI
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 20 Apr 2016
- FDA classified
- 29 Apr 2016
- Reported
- 11 May 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 20 Apr 2016 | Recall initiated by company | |
| 29 Apr 2016 | Classified by FDA | +9 days |
| 11 May 2016 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
An out of tolerance torque tool was used on three joints during the manufacturing process. If the X-ray Tube becomes loose on the CT gantry during operation, this could result in beam tracking errors, potential scan aborts and/or a possible image artifact. There is a secondary safety mechanism to prevent components from being expelled from the gantry if the bolts fail.
Product as listed by the FDA
GE, Revolution CT. The system is intended for head, whole body, cardiac, and vascular X-ray Computed Tomography applications
Where it was distributed
Worldwide Distribution - US including FL, GA, NC, and TX and Internationally to AUSTRALIA, CANADA, CHINA, FRANCE, GERMANY, ITALY, JAPAN, REPUBLIC OF KOREA, NORWAY, PERU, SWEDEN UNITED ARAB EMIRATES, UNITED KINGDOM.
Questions about this recall
Is GE, Revolution CT. The system is intended for head, whole body, cardiac, and vascular recalled?
Yes. GE Medical Systems recalled GE, Revolution CT. The system is intended for head, whole body, cardiac, and vascular on 20 Apr 2016. The recall is Class II and its status is Terminated. Recall number Z-1589-2016.
Why was it recalled?
An out of tolerance torque tool was used on three joints during the manufacturing process. If the X-ray Tube becomes loose on the CT gantry during operation, this could result in beam tracking errors, potential scan aborts and/or a possible image artifact. There is a secondary safety mechanism to prevent components from being expelled from the gantry if the bolts fail.
Which lots are affected?
Mfg Lot or Serial # System ID 442706CN8 727398REVO 443227CN4 940898REVO 00000442994CN0 919684REVCT 443069cn0 404616CTR 00000442968CN4 83141966438 443342CN1 905521RCT1 00000444648CN0 82421100836 00000442479CN2 82421190324 00000443071CN6 82421300072 00000443308CN2 82421040370 00000444206CN7 82421160425 00000442792CN8 M5480791 00000443675CN4 410014CT04 00000443869CN3 A51773126 00000442785CN2 REV015 00000443501CN2 REV013 00000442940CN3 850210884 00000443590CN5 850210890 00000442289CN5 NO1031CT01 00000444156CN4 CT444156CN4 00000442748CN0 CT442748CN0 00000443952CN7 R002CT09 00000443540CN0 A201CT03 00000444038CN4 AE1015CT02 00000443409CN8 00145CTS01 00000443994CN9 00095CTS04
Where was it sold?
Worldwide Distribution - US including FL, GA, NC, and TX and Internationally to AUSTRALIA, CANADA, CHINA, FRANCE, GERMANY, ITALY, JAPAN, REPUBLIC OF KOREA, NORWAY, PERU, SWEDEN UNITED ARAB EMIRATES, UNITED KINGDOM.
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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