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Terminated

EasyDiagnost Eleva Part Number 989605071921

FDA Recall Z-1306-04 · Posted 2004-08-04

Recalling FirmPhilips Medical Systems Sales & Service Region No. America
Recall StatusTerminated
Product CodeKPR
Date Initiated2004-06-08
Date Terminated2006-02-09
Product Quantity46

Reason for Recall

When reviewing images in the module before sending them to PACS or printer the order can be erratic and out of sequence and may cause confusion with the interpretation of the examination.

Firm Action

The firm mailed letters via certified mail to their affected customers beginning on June 8, 2004. The letters instruct their customers to modify the default display on the ViewForum to exam/series date and time until a service representative can install the upgraded software R3.2.

Root Cause

Other

Distribution Pattern

Philips Medical Systems North American Company distributes product to medical facilities nationwide.

Official Source

View FDA Recall →

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

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