medical Class II Updated 2021-02-24

GE Healthcare, LLC recalls System, X-Ray, Tomography, Computed: Revolution Apex, Revolu

Recalled Product

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

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: 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.
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