Stealth Station Cranial Application v.4.5
FDA device recall Z-0711-05 · posted 2005-04-16 · Terminated
Recall details
- Recalling firm
- Medtronic Surgical Navigation Technologies, Inc
- Reason for recall
- The Stealth Station Cranial Application Version 4.5 contains a software anomaly, which may present a hazard to the patient.
- Action taken
- Customers were sent notification letters dated 01/28/05 and 02/02/05.
- Root cause
- Other
- Status
- Terminated
- Product code
- HAW
- Quantity affected
- 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 facili
- Date initiated
- 2005-01-28
- Date posted
- 2005-04-16
- Date terminated
- 2005-04-15
- Location
- Louisville, CO
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STEALTHSTATION (K954276) | Surgical Navigation Technologies, Inc. | 1996-01-24 |