GE Proteus XR/a Radiographic System. GE Medical Systems-Americas Milwaukee, WI. Model Number: 2259988. Product is indica
FDA device recall Z-1790-2012 · posted 2012-06-08 · Terminated
Recall details
- Recalling firm
- General Electric Med Systems LLC
- Reason for recall
- An incident was reported that an operator's finger was pinched between the fixed roller and the gliding tabletop of a Proteus XR/a Table while moving the tabletop with the thumb placed over its edge and fingers underneath
- Action taken
- GE Healthcare sent an "URGENT SAFETY INFORMATION" letter dated May 31, 2006 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter included new operator instructions and warning labels.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- KPR
- Quantity affected
- 3,796 units
- Distribution
- Worldwide Distribution.
- Date initiated
- 2006-05-31
- Date posted
- 2012-06-08
- Date terminated
- 2012-07-31
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SILHOUETTE FC (K993090) | Ge Medical Systems, Inc. | 1999-10-01 |