GE Healthcare Proteus XR/a General Purpose Radiographic System, Models 2259973-4 and 2380179 containing Proteus Operator
FDA device recall Z-1087-2007 · posted 2007-09-25 · Terminated
Recall details
- Recalling firm
- General Electric Med Systems LLC
- Reason for recall
- Labeling; failure to properly label per 21 CFR 1010.2 and 1010.3 -The Operator Console of the Proteus XR/a General Purpose Radiographic Systems were not properly labeled.
- Action taken
- Consignees were notified of the problem by a visit. To address the Proteus System shipped to the field, a Field Modification (FMI) was created to correct units in the field.
- Root cause
- Other
- Status
- Terminated
- Product code
- KPR
- Quantity affected
- 22 units
- Distribution
- Nationwide; including states of WA,KS, CO, NM, NC, FL, MT, AZ, TX, IL, NY, MD, and GA
- Date initiated
- 2006-05-31
- Date posted
- 2007-09-25
- Date terminated
- 2007-12-11
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SILHOUETTE FC (K993090) | Ge Medical Systems, Inc. | 1999-10-01 |