Recall Z-0711-05 ยท HAW Neurological Stereotaxic Instrument
Medtronic Surgical Navigation Technologies, Inc
Stealth Station Cranial Application v.4.5
| Date | Apr 16, 2005 (initiated Jan 28, 2005) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K954276 | STEALTHSTATION Surgical Navigation Technologies, Inc., Jan 24, 1996 |