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Terminated

Philips BV300 Mobile X-Ray System

FDA Recall Z-0526-03 · Posted 2003-02-01

Recalling FirmPhilips Medical Systems
Recall StatusTerminated
Product CodeIZL
Date Initiated2002-09-27
Date Terminated2005-01-12
Product Quantity229 devices

Reason for Recall

The C-bow support can bend and break allowing C-arm to fall from support

Firm 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.

Root Cause

Other

Distribution Pattern

The firm distributed to hospitals, x-ray centers and medical centers throughout the U.S.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K953910PHILIPS BV 300 SERIESPhilips Medical Systems North America, Inc. · 1995-10-18

Official Source

View FDA Recall →

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

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