Z-0711-05

Stealth Station Cranial Application v.4.5

Name: Z-0711-05 Stealth Station Cranial Application v.4.5
Creator: Medtronic Surgical Navigation Technologies, Inc
Published: 2005-01-28
License: https://open.fda.gov/license/

Medtronic Navigation, Inc / initiated 2005-01-28 / Terminated / root cause: software

FDA source

Medtronic Surgical Navigation Technologies, Inc began a recall of Stealth Station Cranial Application v.4.5 on 2005-01-28. The reason FDA records is "The Stealth Station Cranial Application Version 4.5 contains a software anomaly, which may present a hazard to the patient". 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-0711-05
Status: Terminated
Initiated: 2005-01-28
Posted: 2005-04-16
Terminated: 2005-04-15
Recalling firm: Medtronic Navigation, Inc
Product: Stealth Station Cranial Application v.4.5
Product code: HAW Neurological Stereotaxic Instrument
Reason for recall: The Stealth Station Cranial Application Version 4.5 contains a software anomaly, which may present a hazard to the patient.
Root cause tag: software
FDA root cause: Other
Action: Customers were sent notification letters dated 01/28/05 and 02/02/05.
Quantity in commerce: 53 systems with software version 4.5
Distribution: Domestic distribution: FL, CO, AZ, TX, AR, MT, OK, IL, PA, NY, LA, WI, NC, ND, CA, GA, AL, OR, WY, WA, OH, NV. Foreign distribution: Belgium, Czech Republic, China (Malaysia). No military or VA facilites.
Product codes and lots: Catalog Numbers: 960-201 and 9730888. Cranial Application software v.4.5.

Product code HAW

K954276Class IIStealthstationSurgical Navigation Technologies, Inc. / cleared 1996-01-24

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)