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Class 2 Device Recall Philips Automatic Collimator or Beam Limiting Device |
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Date Initiated by Firm |
March 15, 2007 |
Date Posted |
June 14, 2007 |
Recall Status1 |
Terminated 3 on November 15, 2010 |
Recall Number |
Z-0739-2007 |
Recall Event ID |
37767 |
Product Classification |
Collimator - Product Code IZW
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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 |
Recalling Firm/ Manufacturer |
Philips Medical Systems North America Co. Phillips 22100 Bothell Everett Hwy Bothell WA 98021-8431
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For Additional Information Contact |
Sarah Baxter 425-487-7602
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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
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FDA Determined Cause 2 |
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
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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.
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