Recall Z-2449-2019 ยท KPR System, X-Ray, Stationary
GE Healthcare, LLC
Proteus XR/a (SlOK : K993090)
| Date | Sep 20, 2019 (initiated Aug 9, 2019) |
| Status | Open, Classified |
| Reason | Intermittently not receiving an audible exposure indication upon completion of an exposure on the Proteus stationary radiographic system. |
| Root cause | Device Design |
| Action | GE Healthcare will, without charge, remedy the defect or bring the product into compliance with each applicable Federal standard in accordance with a plan to be approved by the Secretary of Health and Human Services, the details of which will be included in a subsequent communication to you or through a GE Healthcare field engineer site visit. A GE Healthcare representative will contact you to arrange for the correction . If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1- 800-437-1171or your local Service Representative. |
| Quantity | 647 US; 167 OUS |
| Distribution | Worldwide - US Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K993090 | SILHOUETTE FC Ge Medical Systems, Inc., Oct 1, 1999 |