FDA Device

Cardiovascular Review Station The IMPAX Cardiovascular suite is a cardiovascular information system, providing image archiving, image display and modality/study specific structured reporting.

Hazard

Echocardiography volume measurements performed within CRS were not reflected correctly in associated Results Management (RM) reports.

What You Should Do

Remedy

The firm, AGFA Healthcare, sent a "Safety Notice" dated January 27, 2011 to all customers. The notice described the product, problem and action to be taken by firm and customer. AGFA informed the customers that a software upgrade was made between December 2008 and February 2010 and instructed the customers to distribute this information to all individuals within their facility and to complete and return the attached URGENT SAFETY NOTICE FEEDBACK FORM via fax to 864-421-1664 or email to debbie.norris@agfa.com. Note: Service Bulletin DD+DIS100.09E, was issued March 2009 and an upgrade from Software Versions 2.12.05 through 2.14.03.SU1 to Software Version CRS 2.14.03.SU2 was required for the impacted sites. Most identified consignees/customers required the software upgrade, but some consignees/customers had already been upgraded prior to the event and did not require additional upgrades. If you have any questions about this matter, please contact the Post Market/QARA North America via email at debbie.norris@agfa.com or call at 864-421-1754.

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Products

Cardiovascular Review Station The IMPAX Cardiovascular suite is a cardiovascular information system, providing image archiving, image display and modality/study specific structured reporting.
Brand
AGFA Corp.
UPC
Software Versions 2.12.05 - 2.14.03.SU1

Units Affected

107

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