Recall StatusTerminated
Date Initiated2013-04-22
Date Terminated2018-04-17
Product Quantity2528 units / 2119 consignees
Reason for Recall
Software Error: The effect of setup on overall navigation accuracy could potentially intensify small inaccuracies arising from individual steps of a complex navigation procedure that may cause an inaccurate display of instruments by the navigation system compared to the actual patient anatomy.
Firm Action
The firm, Brainlab AG, sent out a "Field Safety Notice / Product Notification" CAPA-20130417-000315 Brainlab Cranial Navigation System: Effect of setup on overall navigation accuracy for all versions of software on 4/22/2013 and an update on 5/29/2015.
- From April 22, 2013 has been distributed via email to the consignees.
- UPDATE from May 29, 2015 was distributed via email to the medical users.
An active reply by the consignees will be followed, if necessary via further different communication media.
FIELD SAFETY NOTICE / PRODUCT NOTIFICATION letter describes the product, problem and actions to be taken. The customers were instructed to adhere to the measures described in document Measures to Improve Cranial Navigation Accuracy in the Product Notification letter when using the Brainlab Cranial Navigation System.
Brainlab is requesting that
1. Existing potentially affected customers receive this Product Notification Letter.
2. These customers receive the attached supplement to the Instructions for Use regarding the Brainlab Cranial Navigation System in hardcopy version as an amendment to their current User Manuals. Tentative planned timeline for availability: June 2013
Additionally to advise the appropriate personnel working in your department of the content of Product Notification letter.
If the medical users have the need for further clarification, they are asked to contact their local Brainlab Customer Support Representative.
Customer Hotline: +49 89 99 15 68 44 or +1 800 597 5911 (for US customers) or by
E-mail:
[email protected]. Fax Brainlab AG: + 49 89 99 15 68 33
Address: Brainlab AG (headquarters), Kapellenstrasse 12, 85622 Feldkirchen, Germany.
Root Cause
Software in the Use Environment
Distribution Pattern
Worldwide Distribution: US (Nationwide) including Puerto Rico; and countries of: Algeria, Argentina, Australia, Austria, Bahrain, Belarus, Belgium, Bolivia, Brazil, Canada, Chile, China, Colombia, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Honduras, Hong Kong, Hungary, India, Iran, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Latvia, Lithuania, Malaysia, Mexico, Morocco, Netherlands, Norway, Oman, Pakistan, Panama, Philippines, Poland, Portugal, Qatar, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Turkey, Ukraine, United Arab Emirates, United Kingdom, Venezuela, and Vietnam.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.