Optimus 30
FDA device recall Z-1084-05 · posted 2005-11-08 · Terminated
Recall details
- Recalling firm
- Philips Ultrasound, Inc.
- Reason for recall
- Systems do not comply with the labeling performance standards.
- Action taken
- On/about 2/24/04 the firm''s representatives began visiting sites to apply appropriate labeling. The firrm''s representatives will test units to verify compliance.
- Root cause
- Other
- Status
- Terminated
- Product code
- KPR
- Quantity affected
- 44 units
- Distribution
- Devices were distributed to 38 medical centers and hospitals throughout the US.
- Date initiated
- 2005-02-24
- Date posted
- 2005-11-08
- Date terminated
- 2010-09-27
- Location
- Bothell, WA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PHILIPS BUCKY DIAGNOST FAMILY (K945278) | Philips Medical Systems North America, Inc. | 1994-12-14 |