Proteus XR/a (SlOK : K993090)
FDA device recall Z-2449-2019 · posted 2019-09-20 · Open, Classified
Recall details
- Recalling firm
- GE Healthcare, LLC
- Reason for recall
- Intermittently not receiving an audible exposure indication upon completion of an exposure on the Proteus stationary radiographic system.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Open, Classified
- Product code
- KPR
- Quantity affected
- 647 US; 167 OUS
- Distribution
- Worldwide - US Nationwide
- Date initiated
- 2019-08-09
- Date posted
- 2019-09-20
- Location
- Waukesha, WI
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SILHOUETTE FC (K993090) | Ge Medical Systems, Inc. | 1999-10-01 |