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Terminated

Easy Access Software releases 1.1, 5.2, 6.2 & 7.2

FDA Recall Z-1125-03 · Posted 2003-08-12

Recalling FirmPhilips Medical Systems
Recall StatusTerminated
Product CodeLLZ
Date Initiated2003-06-27
Date Terminated2005-01-12
Product Quantity46 devices

Reason for Recall

If DICOM fields for body part, description or accession number are changed, change won't update on the EasyWeb client or hospital systems.

Firm Action

On 6/25/03 the firm issued a letter dated 6/15/03 to the affected customers. The letter advises of the problem and advises the customer that the firm will install corrected software in affected units.

Root Cause

Other

Distribution Pattern

Devices were distributed to 23 hospitals and medical centers throughout the US.

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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