Philips BV300 Mobile X-Ray System
FDA device recall Z-0526-03 · posted 2003-02-01 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems
- Reason for recall
- The C-bow support can bend and break allowing C-arm to fall from support
- Action taken
- The firm issued a letter dated 9/27/02 to their customers. The letter advised of the problem and that a service representative will visit to inspect unit and correct.
- Root cause
- Other
- Status
- Terminated
- Product code
- IZL
- Quantity affected
- 229 devices
- Distribution
- The firm distributed to hospitals, x-ray centers and medical centers throughout the U.S.
- Date initiated
- 2002-09-27
- Date posted
- 2003-02-01
- Date terminated
- 2005-01-12
- Location
- Bothell, WA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PHILIPS BV 300 SERIES (K953910) | Philips Medical Systems North America, Inc. | 1995-10-18 |