StealthStation S7 Framelink Software version 5.4. Aid for locating anatomical structures and planning surgical trajector
FDA device recall Z-1956-2013 · posted 2013-08-13 · Terminated
Recall details
- Recalling firm
- Medtronic Navigation, Inc.
- Reason for recall
- 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.
- Action taken
- 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 representatives will visit all identified hospitals and upgrade all systems to version 5.4.1. This will account for all consignees.
- Root cause
- Software design
- Status
- Terminated
- Product code
- HAW
- Quantity affected
- 572
- Distribution
- Worldwide Distribution.
- Date initiated
- 2013-07-15
- Date posted
- 2013-08-13
- Date terminated
- 2014-01-29
- Location
- Louisville, CO
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STEALTHSTATION TREATMENT GUIDANCE PLATFORM (K992927) | Surgical Navigation Technologies, Inc. | 1999-12-29 |