FDA Device

IMPAX CV Results Manager/Results Manager Administration Tool

Hazard

Agfa Service technician had incorrectly modified a report template at one site resulting in erroneous anatomic segment locators.

What You Should Do

Remedy

A letter was sent to the consignee on 6/11/2010 indicating what steps would be taken by Agfa concerning the problem. The letter also included a feedback form which was to be returned to Agfa. The recall was expanded and a "URGENT SAFETY NOTICE" was sent to each additional consignee on January 25, 2012. The letter described the potential issue and mitigation. Acknowledgment, via FAX-Back or email, that the information was received and understood has been requested from the additional consignees.

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Products

IMPAX CV Results Manager/Results Manager Administration Tool
Brand
AGFA Corp.
UPC
Model No. L9M2100; Software Versions RM 2.08.12.00.00. All versions of the CV Reporting (RM) are now affected.

Units Affected

358

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