Class 2 Device Recall Philips Automatic Collimator or Beam Limiting Device

• Date Initiated by Firm: March 15, 2007
• Date Posted: June 14, 2007
• Recall Status: Terminated on November 15, 2010
• Recall Number: Z-0739-2007
• Recall Event ID: 37767
• Product Classification: Collimator - Product Code IZW
• Product: 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.
• Code Information: Serial Numbers: 3899, 4334, 4103, 6240, 4560, 4193
• FEI Number: 1000524572
• Recalling Firm/ Manufacturer: Philips Medical Systems North America Co. Phillips; 22100 Bothell Everett Hwy; Bothell WA 98021-8431
• For Additional Information Contact: Sarah Baxter; 425-487-7602
• Manufacturer 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
• FDA Determined 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 in Commerce: 6
• Distribution: Nationwide; Units were distributed to hospitals, radiologists, and health care clinics in IA, LA, ND, PA, and TX, and Washington DC.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.