Device product
BRAINLAB Kick 2; Model/catalogue (article) numbers for Kick: 18170; 18070 UDI (GTIN) for Kick: 04056481006655
Z-2793-2020
Product summary
- Firm
- Brainlab AG
- Event
- Event 86046
- Status
- Terminated
- Classification
- Class II
- Quantity
- 9 unit
- Official record key
device-enforcement:Z-2793-2020
Official wording
Reason: Incorrect manufacturer calibration
Code information: KICK 2 NAVIGATION STATION, Serial Numbers: 0164217001-18170, S/N of affected NDI Camera: P7-12520 2703119001-18170, S/N of affected NDI Camera:P7-20938 2933119001-18170, S/N of affected NDI Camera:P7-21378 6171619001-18170, S/N of affected NDI Camera:P7-18830 8745417001-18170, S/N of affected NDI Camera:P7-15162 9178819001-18170, S/N of affected NDI Camera:P7-16025 9607118001-18170, S/N of affected NDI Camera:P7-13227 5469918001-18170, S/N of affected NDI Camera: P7-14965 KICK NAVIGATION STATION, Serial Number: 1190017001-18070, S/N of affected NDI Camera: P7-06110
Distribution pattern: USA: CA, TX, RI OUS: Armenia; Australia; Brazil; Bulgaria; Canada; Finland; France; Germany; Hong Kong; India; Israel; Italy; Japan; Mongolia; Morocco; Spain
Derived failure modes
-
Unknown
Incorrect manufacturer calibration