Recall Z-0320-2018 ยท HAW Neurological Stereotaxic Instrument
Brainlab AG
Brainlab Navigation System Spine & Trauma 3D with component Brainlab DrapeLink Registration Kit for C-arm Zeihm Vision RFD: Adapter Left
| Date | Nov 16, 2017 |
| Status | Terminated |
| Reason | Due to a human error at a supplier, an unknown number of devices within one specific production lot of Brainlab DrapeLink Adapters (Left/Right) were not manufactured according to defined specifications. |
| Root cause | Nonconforming Material/Component |
| Action | Customers were notified, via email on approximately 11/16/2017. Instructions included to identify all affected devices on hand, cease use of the affected device, and a Brainlab Customer Support Representative will contact the customer to arrange a service visit to replace the item |
| Quantity | 80 devices total |
| Distribution | Distributed in the US to Kansas. Distributed internationally to Australia, Finland, France, Germany, Hong Kong, Ireland, Japan, Netherlands, Norway, Sweden, Switzerland, Taiwan, Turkey, United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K070106 | VV FLUORO 3D Brainlab AG, Apr 23, 2007 |