Recall Z-0739-2007 ยท IZW Collimator, Automatic, Radiographic
Philips Medical Systems North America Co. Phillips
Philips Collimators, Model numbers: 9896 010 00614, 9896 010 00615, 9804 607 00301, and 9804 602 83501. Product is a Collimator/ Beam Limiting Device and are replacement components for the Bucky Diagnost TH X-ray system.
| Date | Jun 14, 2007 (initiated Mar 15, 2007) |
| Status | Terminated |
| Reason | The Collimator field-defining light beam does not meet the light field contrast ratio requirement of 4:1. System is non-compliant with performance standard (1020.31 (d)(2)(iii) 21 CFR |
| Root cause | Other |
| Action | Firm issued letter on 03/20/2007 to consignees advising them that firm representatives will contact consignee to replace collimators at no charge. |
| Quantity | 6 |
| Distribution | Nationwide; Units were distributed to hospitals, radiologists, and health care clinics in IA, LA, ND, PA, and TX, and Washington DC. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.