Z-0526-03

Philips BV300 Mobile X-Ray System

Name: Z-0526-03 Philips BV300 Mobile X-Ray System
Creator: Philips Medical Systems
Published: 2002-09-27
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2002-09-27 / Terminated

FDA source

Philips Medical Systems began a recall of Philips BV300 Mobile X-Ray System on 2002-09-27. The reason FDA records is "The C-bow support can bend and break allowing C-arm to fall from support". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0526-03
Status: Terminated
Initiated: 2002-09-27
Posted: 2003-02-01
Terminated: 2005-01-12
Recalling firm: Philips North America LLC
Product: Philips BV300 Mobile X-Ray System
Product code: IZL System, X-Ray, Mobile
Reason for recall: The C-bow support can bend and break allowing C-arm to fall from support
FDA root cause: Other
Action: The firm issued a letter dated 9/27/02 to their customers. The letter advised of the problem and that a service representative will visit to inspect unit and correct.
Quantity in commerce: 229 devices
Distribution: The firm distributed to hospitals, x-ray centers and medical centers throughout the U.S.
Product codes and lots: Part numbers 9896 000 06801 and 9806 000 06802 with serial numbers: DBXXXX - all DBXXXX - all DDXXXX - all DEXXXX - all DG0001-DG0129 DH0001-DH0033 DJ0001 - DJ0152 DK0001 - DK 0076

Product code IZL

K953910Class IIPhilips Bv 300 SeriesPhilips Medical Systems North America, Inc. / cleared 1995-10-18

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)