FDA Device recall Z-0320-2018
Brainlab Navigation System Spine & Trauma 3D with component Brainlab DrapeLink Registration Kit for C-arm Zeihm Vision RFD: Adapter Left
- FDA Device
- Class II
- terminated
- Published 2018-01-17
On 2018-01-17 the FDA classified a Class II recall of Brainlab Navigation System Spine & Trauma 3D with component Brainlab DrapeLink Registration Kit for C-arm Zeihm Vision RFD: Adapter Left by Brainlab Ag, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0320-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-11-16 |
| Published | 2018-01-17 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Brainlab Ag |
| Distribution | KS |
Product
Brainlab Navigation System Spine & Trauma 3D with component Brainlab DrapeLink Registration Kit for C-arm Zeihm Vision RFD: Adapter Left
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.
Identifiers
| code_info | Model No. 19154, UDI GTIN 04056481132187. Model No. 19154-04, UDI No. GTIN 04056481113926. Serial No. range 745931600…Model No. 19154, UDI GTIN 04056481132187. Model No. 19154-04, UDI No. GTIN 04056481113926. Serial No. range 7459316001 - 7459316027 and 7714816001 - 7714816017. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0320-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.