|
Class 2 Device Recall Brainlab Cranial Image Guided Surgery System / Instrument, Stereotaxic |
|
Date Initiated by Firm |
August 31, 2020 |
Create Date |
October 06, 2020 |
Recall Status1 |
Terminated 3 on February 17, 2021 |
Recall Number |
Z-0056-2021 |
Recall Event ID |
86438 |
510(K)Number |
K092467
|
Product Classification |
Neurological stereotaxic Instrument - Product Code HAW
|
Product |
Ultrasound Navigation Software 1.0 and Ultrasound Integration Software for Cranial/ENT Navigation 3.0.x and 3.1.x - Product Usage: intended to be an intra-operative image guided localization system to enable minimally invasive surgery. |
Code Information |
Model/catalogue numbers: 22582 IGSONIC BK MEDICAL SOFTWARE 22582A ULTRASOUND INTEGRATION SW (BK) 22582B ULTRASOUND INTEGRATION SW 22583 LICENSE UPDATE TO IGSONIC SW FOR BK MED 26506 ULTRASOUND SW BK800 SUBSCRIPTION 26506A ULTRASOUND SW BK SUBSCRIPTION 26508A ULTRASOUND SW BK UPDATE UDI: The GTIN for Ultrasound Navigation 1.0 is: 04056481140137 The GTIN for Cranial/ENT Navigation 3.1 is: 04056481132439 |
Recalling Firm/ Manufacturer |
Brainlab AG Olof-palme-str. 9 Munich Germany
|
Manufacturer Reason for Recall |
Brainlab Ultrasound Navigation Software does not support the modification of the probe's image width.
|
FDA Determined Cause 2 |
Software design |
Action |
The intraoperative Brainlab Ultrasound Navigation Software does not support the modification of the probes image width, an optional feature of the BK Medical Ultrasound System, resulting in an incorrect display of the depth of the ultrasound overlay by the navigation for non-linear
ultrasound probes, with the deviation depending on the probe and the difference between the calibrated and used image width. |
Quantity in Commerce |
271 units |
Distribution |
Worldwide distribution - US Nationwide distribution including in the states of Illinois, Massachusetts, Texas, California, Idaho, Missouri, Oregon, Connecticut and the countries of Australia, Austria, Belgium, Brazil, Canada, China, Curacao, Czech Republic, Egypt, Finland, France, Germany, Switzerland, Netherlands, Hong Kong, India, Indonesia, Israel, Italy, Japan, Kuwait, Malaysia, Myanmar, Norway, Pakistan, Romania, Slovakia, South Africa, Spain, Sweden, Thailand, Turkey and United Kingdom. |
Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database |
510(K)s with Product Code = HAW and Original Applicant = BRAINLAB AG
|
|
|
|