Z-2781-2011

DICOM Query/Retrieve, version 1.1.4. Individual part # 9733808, or as part of a system order, DICOM Q/R...

Name: Z-2781-2011 DICOM Query/Retrieve, version 1.1.4. Individual part # 9733808, or as part of a system order, DICOM Q/R...
Creator: Medtronic Navigation, Inc.
Published: 2011-06-02
License: https://open.fda.gov/license/

Medtronic Navigation, Inc / initiated 2011-06-02 / Terminated / root cause: software

FDA source

Medtronic Navigation, Inc. began a recall of 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... on 2011-06-02. The reason FDA records is "Software allows incorrect patient or patient history to be displayed". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2781-2011
Status: Terminated
Initiated: 2011-06-02
Posted: 2011-07-11
Terminated: 2011-07-12
Recalling firm: Medtronic Navigation, Inc
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.
Product code: HAW Neurological Stereotaxic Instrument
Reason for recall: Software allows incorrect patient or patient history to be displayed.
Root cause tag: software
FDA root cause: Software design
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.
Quantity in commerce: 90
Distribution: 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.
Product codes and lots: DICOM Query/Retrieve, version 1.1.4. Individual part # 9733808, or as part of a system order, DICOM Q/R Software Kit, part # 9733933.

Product code HAW

K050438Class IIStealthstation System UpdateMedtronic Surgical Navigation Technologies / cleared 2005-06-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)