ROSA One 3.1 Brain Application
Reported: February 19, 2020 Initiated: January 6, 2020 #Z-1151-2020
Product Description
ROSA One 3.1 Brain Application
Reason for Recall
Some cross-sectional images from the image acquisitions of the patients head may not be reconstructed/displayed properly in two and three dimension views when using ROSA Brain software, potentially compromising the surgery planning.
Details
- Recalling Firm
- MEDTECH SAS
- Units Affected
- 39 units
- Distribution
- US Nationwide
- Location
- Montpellier
Frequently Asked Questions
What product was recalled? ▼
ROSA One 3.1 Brain Application. Recalled by MEDTECH SAS. Units affected: 39 units.
Why was this product recalled? ▼
Some cross-sectional images from the image acquisitions of the patients head may not be reconstructed/displayed properly in two and three dimension views when using ROSA Brain software, potentially compromising the surgery planning.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 19, 2020. Severity: Moderate. Recall number: Z-1151-2020.
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