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Terminated

Easy Access Image Management System with CL.Net.

FDA Recall Z-0695-05 · Posted 2005-04-08

Recalling FirmPhilips Medical Systems Sales & Service Region No. America
Recall StatusTerminated
Product CodeLMB
Date Initiated2005-02-16
Date Terminated2006-02-13
Product Quantity60

Reason for Recall

Failure to update correctly when re-transmitting an image from the modality.

Firm Action

The firm mailed a letter on January 31, 2005, certified return receipt to their customers advising that a service representative will visit each site and install new software.

Root Cause

Other

Distribution Pattern

Devices distributed to 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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