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Terminated

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FDA Recall Z-1128-03 · Posted 2003-08-12

Recalling FirmPhilips Medical Systems
Recall StatusTerminated
Product CodeLLZ
Date Initiated2002-02-13
Date Terminated2005-01-12
Product Quantity28

Reason for Recall

Potential for incorrect body part information

Firm Action

A letter dated 2/13/02 was issued to customers advising that a representative from the firm will install new software.

Root Cause

Other

Distribution Pattern

The firm distributed units to hospitals and medical centers located throughout the US.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K982769MITRA IMAGING INC. EXHIBITMitra Imaging, Inc. · 1998-11-03

Official Source

View FDA Recall →

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

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