FDA Medical Device Recalls (openFDA)
Medtronic Surgical Navigation Technologies, Inc: Stealth Station Cranial Application v.4.5
- Recall number
- Z-0711-05
- Recalling firm
- Medtronic Surgical Navigation Technologies, Inc
- Product
- Stealth Station Cranial Application v.4.5
- Status
- Terminated
- Initiated
- 2005-01-28
- Posted
- 2005-04-16
- Terminated
- 2005-04-15
- Reason
- The Stealth Station Cranial Application Version 4.5 contains a software anomaly, which may present a hazard to the patient.
- Root cause
- Other
- Action
- Customers were sent notification letters dated 01/28/05 and 02/02/05.
- Quantity
- 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.
- Lot, serial or model codes
- Catalog Numbers: 960-201 and 9730888. Cranial Application software v.4.5.
- 510(k) numbers
- ["K954276"]
- PMA numbers
- not on file
- Product code
- HAW
- Firm FEI
- 1000517638
- Firm city
- Louisville
- Firm state
- CO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28