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Terminated

Thoravision II Thorax and Mass Chest Column. Part numbers 4512 130 07812.

FDA Recall Z-0370-05 · Posted 2004-12-24

Recalling FirmPhilips Medical Systems Sales & Service Region No. America
Recall StatusTerminated
Product CodeKPR
Date Initiated2004-12-01
Date Terminated2006-02-10
Product Quantity44 total units (Thoravision I and II)

Reason for Recall

X-Ray system may fall downward and could possibly hit the patient.

Firm Action

A notification was sent to all customers via certified mail, return receipt requested starting on December 1, 2004. Field Service Engineers will contact the customers to schedule a time for the column exchange starting mid-November and to be completed no later than Mid June 2005.

Root Cause

Other

Distribution Pattern

The firm distributed this product to hospitals and medical centers nationwide.

Official Source

View FDA Recall →

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

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