Philips Collimators, Model numbers: 9896 010 00614, 9896 010 00615, 9804 607 00301, and 9804 602 83501. Product is a Col
FDA device recall Z-0739-2007 · posted 2007-06-14 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems North America Co. Phillips
- Reason for recall
- 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
- Action taken
- Firm issued letter on 03/20/2007 to consignees advising them that firm representatives will contact consignee to replace collimators at no charge.
- Root cause
- Other
- Status
- Terminated
- Product code
- IZW
- Quantity affected
- 6
- Distribution
- Nationwide; Units were distributed to hospitals, radiologists, and health care clinics in IA, LA, ND, PA, and TX, and Washington DC.
- Date initiated
- 2007-03-15
- Date posted
- 2007-06-14
- Date terminated
- 2010-11-15
- Location
- Bothell, WA
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