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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Philips Medical Systems North America Co. Phillips
Lot Codes / Batch Numbers
Serial Numbers: 3899, 4334, 4103, 6240, 4560, 4193
Products Sold
Serial Numbers: 3899, 4334, 4103, 6240, 4560, 4193
Philips Medical Systems North America Co. Phillips is recalling Philips Collimators, Model numbers: 9896 010 00614, 9896 010 00615, 9804 607 00301, and 9804 602 835 due to The Collimator field-defining light beam does not meet the light field contrast ratio requirement of 4:1. System is non-compliant with performance sta. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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
Recommended Action
Per FDA guidance
Firm issued letter on 03/20/2007 to consignees advising them that firm representatives will contact consignee to replace collimators at no charge.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026