FDA Device recall Z-1589-2016
GE, Revolution CT. The system is intended for head, whole body, cardiac, and vascular X-ray Computed Tomography applications
- FDA Device
- Class II
- terminated
- Published 2016-05-11
On 2016-05-11 the FDA classified a Class II recall of GE, Revolution CT. The system is intended for head, whole body, cardiac, and vascular X-ray Computed Tomography applications by Ge Medical Systems, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1589-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-04-20 |
| Published | 2016-05-11 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Ge Medical Systems |
| Distribution | FL, GA, NC, TX |
Product
GE, Revolution CT. The system is intended for head, whole body, cardiac, and vascular X-ray Computed Tomography applications
Reason
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.
Identifiers
| code_info | Mfg Lot or Serial # System ID 442706CN8 727398REVO 443227CN4 940898REVO 00000442994CN0 919684REVCT 443069cn0 404616…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1589-2016%22
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