Clea Stand Ceiling used with the Integris X-Ray System H5000, Allura 12/15, Allura 9C
FDA device recall Z-0099-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems Sales & Service Region No. America
- Reason for recall
- The cable carrier and cables may fall after repeat collisions with OR lamps, radiation shields or other supported accessories.
- Action taken
- The firm sent a letter dated, October 10, 2003 indicating the firm''s service representatives will upgrade the cable carrier by mounting a safety catch inside the cable carrier.
- Root cause
- Other
- Status
- Terminated
- Product code
- EHD
- Quantity affected
- 536 units
- Distribution
- The firm distributes to hospitals and medical centers nationwide.
- Date initiated
- 2003-10-10
- Date posted
- 2004-07-20
- Date terminated
- 2005-01-13
- Location
- Bothell, WA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PHILIPS INTEGRIS H5000 (K971365) | Philips Medical Systems North America, Inc. | 1997-05-14 |