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.
FDA Recall Z-0739-2007 · Posted 2007-06-14
Recalling FirmPhilips Medical Systems North America Co. Phillips
Recall StatusTerminated
Product CodeIZW
Date Initiated2007-03-15
Date Terminated2010-11-15
Product Quantity6
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
Firm Action
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
Distribution Pattern
Nationwide; Units were distributed to hospitals, radiologists, and health care clinics in IA, LA, ND, PA, and TX, and Washington DC.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.