Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

BV 25 Gold Mobile X-Ray System

FDA Recall Z-1454-04 · Posted 2004-09-15

Recalling FirmPhilips Medical Systems Sales & Service Region No. America
Recall StatusTerminated
Product CodeIZL
Date Initiated2004-07-20
Date Terminated2006-02-09
Product Quantity1900 total devices (includes BV25, BV 25 Gold, BV26, BV29, BV212

Reason for Recall

Potential for c-arm to move due to loose screws

Firm 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.

Root Cause

Other

Distribution Pattern

The units are distributed to hospitals and medical centers throughout the U.S.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K921255PHILIPS BV26 MOBILE C-ARM STANDPhilips Medical Systems, Inc. · 1992-05-18

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑