Company:Medtronic Navigation, Inc
Date of Enforcement Report 8/3/11
Class ll:
PRODUCT
DICOM Query/Retrieve, version 1.1.4. Individual part # 9733808, or as part of a system order, DICOM Q/R Software Kit, part # 9733933. DICOM Query/Retrieve software is installed on Medtronic StealthStation systems. Product Usage: DICOM Query/Retrieve software enables the user to query a hospital Picture Archiving and Communication System (PACS) for patient DICOM scans. The user can then transfer the identified scan to a Medtronic StealthStation system. Recall # Z-2781-2011
REASON
Software allows incorrect patient or patient history to be displayed.
RECALLING FIRM/MANUFACTURER
Medtronic Navigation, Inc., Louisville, CO, by letter dated June 2, 2011. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
81 units
DISTRIBUTION
Nationwide and Internationally
