Z-1456-04

BV29 Mobile X-Ray System

Name: Z-1456-04 BV29 Mobile X-Ray System
Creator: Philips Medical Systems Sales & Service Region No. America
Published: 2004-07-20
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2004-07-20 / Terminated

FDA source

Philips Medical Systems Sales & Service Region No. America began a recall of BV29 Mobile X-Ray System on 2004-07-20. The reason FDA records is "Potential for c-arm to move due to loose screws". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1456-04
Status: Terminated
Initiated: 2004-07-20
Posted: 2004-09-15
Terminated: 2006-02-09
Recalling firm: Philips North America LLC
Product: BV29 Mobile X-Ray System
Product code: IZL System, X-Ray, Mobile
Reason for recall: Potential for c-arm to move due to loose screws
FDA root cause: Other
Action: Beginning on 7/20/04 the firm sent a letter dated 7/19/04 via certified mail. Mailing was completed 7/27/04. The letter advises customers of the problem, advises how to determine of the screws are loose, and if so to contact Philips. The letter also advises that a respresentative will visit each consignee to inspect and correct the problem.
Quantity in commerce: 1900 total devices (includes BV25, BV 25 Gold, BV26, BV29, BV212
Distribution: The units are distributed to hospitals and medical centers throughout the U.S.
Product codes and lots: see site numbers listed above for BV 25

Product code IZL

K910115Class IIPhilips Bv-29 Imaging SystemPhilips Medical Systems, Inc. / cleared 1991-02-20

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)