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Terminated

Easy Access PACS System with software Release 5, 6.2, or 7.2

FDA Recall Z-1223-03 · Posted 2003-09-12

Recalling FirmPhilips Medical Systems
Recall StatusTerminated
Product CodeLLZ
Date Initiated2002-02-13
Date Terminated2005-04-11
Product Quantity46 units

Reason for Recall

Potential display of an incorrect body part description on patient images.

Firm Action

On 2/13/02 the firm issued a letter to their consignees. The letter provided a remedy to the situtaion.

Root Cause

Other

Distribution Pattern

The firm distributed units to 46 hospitals and medical centers located throughout the U.S.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K983447WISE (II) IMAGE MANAGEMENT SYSTEMSectra-Imtec AB · 1998-10-29

Official Source

View FDA Recall →

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

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