Here are five key points:
1. The device’s real-time display has inaccuracies that could cause injury or death.
2. The real-time display is intended to represent patient anatomy so surgeons can map out procedures preoperatively. The digital picture does not match patient anatomy, however.
3. The FDA’s Class I recall includes the company’s cranial-navigation systems before 3.0 and IGS systems distributed between May 1996 and May 2015.
4. This recall impacts 1,021 units in Arkansas, California, Colorado, Maryland, North Carolina, Ohio, Pennsylvania and Texas.
5. Brainlab plans to amend the issue with a new safety mechanism.
More articles on devices:
Active Implants initiates 2nd NUsurface meniscus implant trial: 4 things to know
BONESUPPORT’s CERAMENT registry hits 230 cases: 5 notes
Episurf Medical’s μifidelity platform reaches 100 case milestone: 3 points
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