FDA Device

IMPAX RIS QDOC 5.8

Hazard

Patient name displayed (printed) on the Patient Report was the wrong patient name.

What You Should Do

Remedy

On January 8, 2014, an "URGENT FIELD SAFETY NOTICE" (UFSN) letter was emailed to consignees. The letter described the safety alert and mitigation, including directions to consignees as to how the disable Microsoft Word Background Printing. Acknowledgment via FAX-Back or email, that the information was received and understood was requested from the consignees.

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Products

IMPAX RIS QDOC 5.8
Brand
AGFA Corp.
UPC
Software IMPAX RIS 58 and higher

Units Affected

14

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