Events

Recall of Device Recall Brainlab Navigation System Spine & Trauma 3D

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Brainlab AG.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    78715
  • Event Risk Class
    Class 2
  • Event Number
    Z-0320-2018
  • Event Initiated Date
    2017-11-16
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=160217
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Neurological stereotaxic Instrument - Product Code HAW
  • 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.
  • 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

Device

Device Recall Brainlab Navigation System Spine & Trauma 3D
  • Model / Serial
    Model No. 19154, UDI GTIN 04056481132187. Model No. 19154-04, UDI No. GTIN 04056481113926. Serial No. range 7459316001 - 7459316027 and 7714816001 - 7714816017.
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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
  • Manufacturer
    Brainlab AG

Manufacturer

Brainlab AG
  • Manufacturer Address
    Brainlab AG, Olof-Palme-Strasse 9, Munich Germany
  • Manufacturer Parent Company (2017)
    Brainlab AG
  • Source
    USFDA