Recall Z-1457-04 ยท IZL System, X-Ray, Mobile
Philips Medical Systems Sales & Service Region No. America
BV212 Mobile X-Ray System
| Date | Sep 15, 2004 (initiated Jul 20, 2004) |
| Status | Terminated |
| Reason | Potential for c-arm to move due to loose screws |
| Root cause | Other |
| Action | 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. |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K910115 | PHILIPS BV-29 IMAGING SYSTEM Philips Medical Systems, Inc., Feb 20, 1991 |