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Terminated

Tomoscan

FDA Recall Z-0682-05 · Posted 2005-04-06

Recalling FirmPhilips Medical Systems Sales & Service Region No. America
Recall StatusTerminated
Product CodeKPS
Date Initiated2005-02-10
Date Terminated2008-05-09
Product Quantity138

Reason for Recall

Potential for shift of reference lines.

Firm Action

On 2/10/05 the firm''s field engineers began visiting customer sites providing them with an addendum to the Instructions for Use Manual.

Root Cause

Other

Distribution Pattern

Devcices were distributed to hospitals and medical centers throughout the U.S.

Official Source

View FDA Recall →

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

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