BV26 Mobile X-Ray System
FDA device recall Z-1455-04 · posted 2004-09-15 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems Sales & Service Region No. America
- Reason for recall
- Potential for c-arm to move due to loose screws
- Action taken
- Beginning on 7/20/04 the firm sent a letter dated 7/19/04 via certified mail. Mailing was completed 7/27/04. The letter advises customers of the problem, advises how to determine of the screws are loose, and if so to contact Philips. The letter also advises that a respresentative will visit each consignee to inspect and correct the problem.
- Root cause
- Other
- Status
- Terminated
- Product code
- IZL
- Quantity affected
- 1900 total devices (includes BV25, BV 25 Gold, BV26, BV29, BV212
- Distribution
- The units are distributed to hospitals and medical centers throughout the U.S.
- Date initiated
- 2004-07-20
- Date posted
- 2004-09-15
- Date terminated
- 2006-02-09
- 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 BV26 MOBILE C-ARM STAND (K921255) | Philips Medical Systems, Inc. | 1992-05-18 |