Brainlab Navigation System Spine & Trauma 3D with component Brainlab DrapeLink Registration Kit for C-arm Zeihm Vision RFD: Adapter Left
Check against the official notice below — it lists the full affected range.
Brainlab AG has recalled 80 Brainlab DrapeLink Registration Kit Adapters (Left) due to manufacturing defects caused by human error at a supplier. The affected devices were not manufactured according to specifications. The recalled devices include Model No. 19154 and Model No. 19154-04 with specific serial number ranges, and were distributed in the United States (Kansas) and internationally to Australia, Finland, France, Germany, Hong Kong, Ireland, Japan, Netherlands, Norway, Sweden, Switzerland, Taiwan, Turkey, and the United Kingdom.
The recall record does not specify a remedy or recommended action for consumers who may have affected devices.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. 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. Quantity: 80 devices total Lot/code info: Model No. 19154, UDI GTIN 04056481132187. Model No. 19154-04, UDI No. GTIN 04056481113926. Serial No. range 7459316001 - 7459316027 and 7714816001 - 7714816017.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.