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.
FDA Recall Z-2781-2011 · Posted 2011-07-11
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Recalling FirmMedtronic Navigation, Inc.
Recall StatusTerminated
Product CodeHAW
Date Initiated2011-06-02
Date Terminated2011-07-12
Product Quantity90
Reason for Recall
Software allows incorrect patient or patient history to be displayed.
Firm Action
Medtronic Navigation sent a "FIELD SAFETY NOTICE" letter dated June 2, 2011 to all affected customers. The letter identified the product, problem and description of the corrective action. The letter states that Medtronic field representatives will visit each consumer/user and upgrade the version of DICOM Q/R to 1.1.5. Further information is available by contacting Medtronic Navigation Technical Services at 1-800-595-9709.
Root Cause
Software design
Distribution Pattern
Worldwide distribution - USA (nationwide) -- including states of: TX, NC, ID, FL, OH, UT, CA, TN, IL, AZ, NE, LA, PA, OR, AR, MI, NJ, MD and countries of: Canada, Denmark, Finland, Great Britain, Hungary, Ireland, Japan, Korea, Netherlands, Poland, South Africa, Spain, and Taiwan.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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