Recall Z-1956-2013 ยท HAW Neurological Stereotaxic Instrument
Medtronic Navigation, Inc.
StealthStation S7 Framelink Software version 5.4. Aid for locating anatomical structures and planning surgical trajectories in open and percutaneous procedures.
| Date | Aug 13, 2013 (initiated Jul 15, 2013) |
| Status | Terminated |
| Reason | Medtronic Navigation, Inc. has initiated a field correction to their Framelink software version 5.4 which can be used on Medtronic Navigation StealthStation 57 and i7 systems or a Medtronic Planning Station due to the potential of discrepancy between the exam image and the displayed measurement or overlay under certain conditions of use. |
| Root cause | Software design |
| Action | A Field Safety Notice was sent on 7/15/13 to users informing them that the Framelink software version 5.4 has been revised to correct the software anomalies described in this letter. A new version will be installed on their system(s) by a Medtronic Navigation representative. Until the software upgrade has been installed on their system, do not use high resolution examinations (greater than 256 x 256). If users are not sure of the exam resolution being used, firm recommend contacting the hospital imaging department or local Medtronic Navigation representative for assistance. Medtronic represe |
| Quantity | 572 |
| Distribution | Worldwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K992927 | STEALTHSTATION TREATMENT GUIDANCE PLATFORM Surgical Navigation Technologies, Inc., Dec 29, 1999 |