FDA Device

System, X-Ray, Tomography, Computed: Revolution Apex, Revolution CT with Apex Edition

Hazard

GE Healthcare has become aware of a potential issue on Revolution Apex, Revolution CT with Apex Edition, Revolution CT, and Revolution CT ES systems where the table pinch protector could be damaged or missing leading to exposed table screws which could cause a laceration due to a sharp edge.

What You Should Do

Remedy

The manufacturer sent an "Urgent Medical Device Correction" letter (GEHC Ref# 25496) to customers with affected systems on 12/17/2020.

Products

System, X-Ray, Tomography, Computed: Revolution Apex, Revolution CT with Apex Edition
Brand
GE Healthcare, LLC
UPC
Model Numbers:  5590000-20: REV2A1900002CN, REV2A2000013CN, REV2A2000025CN, REV2A2000006CN, REV2A2000003CN, REV2A2000015CN, REV2A1900003CN, REV2A2000007CN, REV2A2000022CN, REV2A2000010CN, REV2A2000030CN, REV2A2000029CN, REV2A2000017CN, REV2A2000001CN, REV2A2000002CN, REV2A2000031CN, REV2A2000020CN, REV2A2000024CN, REV2A2000023CN, REV2A2000012CN, REV2A2000016CN, REV2A1900001CN, REV2A2000027CN, REV2A2000028CN, REV2A2000018CN, REV2A1900005CN, REV2A2000009CN, REV2A2000026CN, REV2A2000021CN, REV2A2000011CN  5590000-21: xxx, xxx, xxx* (66 units) *serial number information current as of 01/21/2021.

Units Affected

96 units