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.
Check against the official notice below — it lists the full affected range.
Brainlab AG has recalled Ultrasound Navigation Software 1.0 and Ultrasound Integration Software for Cranial/ENT Navigation versions 3.0.x and 3.1.x, which are used during surgery to help guide procedures. The software does not support modification of the probe's image width. A total of 271 units have been distributed worldwide, including throughout the United States and numerous countries across Europe, Asia, the Middle East, Australia, and South America.
The affected products include several model and catalogue numbers related to BK Medical ultrasound integration software and subscriptions. The recall record does not specify a remedy or course of action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Brainlab Ultrasound Navigation Software does not support the modification of the probe's image width.
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, Norwa Quantity: 271 units 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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.