—#51483

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.

FDA product code: IZW — Collimator, Automatic, Radiographic
Device class: Class 2
Medical specialty: Radiology
Affected lot / code info: Serial Numbers: 3899, 4334, 4103, 6240, 4560, 4193

Why it was recalled

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

Root cause (FDA determination)

Other

Action the firm took

Firm issued letter on 03/20/2007 to consignees advising them that firm representatives will contact consignee to replace collimators at no charge.

Recalling firm

Firm: Philips Medical Systems North America Co. Phillips
Address: 22100 Bothell Everett Hwy, Bothell, Washington 98021-8431

Distribution

Distribution pattern: Nationwide; Units were distributed to hospitals, radiologists, and health care clinics in IA, LA, ND, PA, and TX, and Washington DC.

Timeline

Recall initiated: 2007-03-15
Posted by FDA: 2007-06-14
Terminated: 2010-11-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #51483. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.