Device 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.
Z-0056-2021
Product summary
- Firm
- Brainlab AG
- Event
- Event 86438
- Status
- Terminated
- Classification
- Class II
- Quantity
- 271 units
- Official record key
device-enforcement:Z-0056-2021
Official wording
Reason: Brainlab Ultrasound Navigation Software does not support the modification of the probe's image width.
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
Distribution pattern: 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.
Derived failure modes
-
Unknown
Brainlab Ultrasound Navigation Software does not support the modification of the probe's image width.