Z-0739-2007

Philips Collimators, Model numbers: 9896 010 00614, 9896 010 00615, 9804 607 00301, and 9804 602 83501...

Name: Z-0739-2007 Philips Collimators, Model numbers: 9896 010 00614, 9896 010 00615, 9804 607 00301, and 9804 602 83501...
Creator: Philips Medical Systems North America Co. Phillips
Published: 2007-03-15
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2007-03-15 / Terminated

FDA source

Philips Medical Systems North America Co. Phillips began a recall of 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... on 2007-03-15. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0739-2007
Status: Terminated
Initiated: 2007-03-15
Posted: 2007-06-14
Terminated: 2010-11-15
Recalling firm: Philips North America LLC
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.
Product code: IZW Collimator, Automatic, Radiographic
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 root 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.
Product codes and lots: Serial Numbers: 3899, 4334, 4103, 6240, 4560, 4193

Product code IZW

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)