Reported Oct 14, 2020 · Terminated
Ultrasound Navigation Software 1.0 and Ultrasound Integration Software for Cranial/ENT Navigation 3.0.x and 3.1.x -…
Brainlab AG
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Brainlab AG · Olof-palme-str. 9 · Munich, N/A · N/A
Is this the product you have?
- Ultrasound Navigation Software 1.0 and Ultrasound Integration Software for Cranial/ENT Navigation 3.0.x and 3.1
- x - Product Usageintended to be an intra-operative image guided localization system to enable minimally invasive surgery
- Lot codes and dates
- Model/catalogue numbers22582 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 UDIThe GTIN for Ultrasound Navigation 1.0
- is04056481140137 The GTIN for Cranial/ENT Navigation 3.1
- is04056481132439
- Amount recalled
- 271 units
Where it was sold
Why it was recalled
Brainlab Ultrasound Navigation Software does not support the modification of the probe's image width.
This product could cause temporary or reversible health problems — stop using it.
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