Brainlab Navigation System Spine & Trauma 3D with component… recallZ-0320-2018 · Brainlab AG · initiated Nov 16, 2017
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Brainlab AG or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Nonconforming Material/Component
What the company is doing
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
Recall details
- Recall number
- Z-0320-2018
- Status
- Terminated
- Initiated by the company
- Nov 16, 2017
- Recalling firm
- Brainlab AG
- Quantity
- 80 devices total
- Product code
- HAW
- FDA submissions
- K070106
- 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.
Product description
Brainlab Navigation System Spine & Trauma 3D with component Brainlab DrapeLink Registration Kit for C-arm Zeihm Vision RFD: Adapter Left
Code information (models, lots, serial numbers)
Model No. 19154, UDI GTIN 04056481132187. Model No. 19154-04, UDI No. GTIN 04056481113926. Serial No. range 7459316001 - 7459316027 and 7714816001 - 7714816017.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- C-ARM ADAPTER ZIEHM RFD 3D LEFT 19154-04Brainlab SE · Orthopedic Stereotaxic Instrument1 recall0 reports
Other devices under the same FDA submission
1 device cleared under K070106 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Navigation Software Spine & Trauma 3D 2.5Brainlab SE · Neurological Stereotaxic Instrument5 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page