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U.S. Department of Health and Human Services

Class 2 Device Recall DICOM Query/Retrieve, version 1.1.4

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 Class 2 Device Recall DICOM Query/Retrieve, version 1.1.4see related information
Date Initiated by FirmJune 02, 2011
Date PostedJuly 11, 2011
Recall Status1 Terminated 3 on July 12, 2011
Recall NumberZ-2781-2011
Recall Event ID 54621
510(K)NumberK050438 
Product Classification Neurological stereotaxic instrument - Product Code HAW
ProductDICOM 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.
Code Information DICOM Query/Retrieve, version 1.1.4. Individual part # 9733808, or as part of a system order, DICOM Q/R Software Kit, part # 9733933.
FEI Number 1000517638
Recalling Firm/
Manufacturer		 Medtronic Navigation, Inc.
826 Coal Creek Cir
Louisville CO 80027-9710
For Additional Information Contact
800-595-9709
Manufacturer Reason
for Recall		Software allows incorrect patient or patient history to be displayed.
FDA Determined
Cause 2		Software design
ActionMedtronic 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.
Quantity in Commerce90
DistributionWorldwide 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = HAW
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