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.
- Recall Initiated
- August 31, 2020
- Terminated
- February 17, 2021
- Recall Number
- Z-0056-2021
- Quantity
- 271 units
Reason for Recall
Brainlab Ultrasound Navigation Software does not support the modification of the probe's image width.
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.
Lot / Code Info
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
Root Cause
Software design
Action Taken
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.