Reported Jun 16, 2021 · Terminated
ExacTrac Dynamic software, Model 20910-01B ETD Positioning and Monitoring Installer 1.0.2 - Product Usage: intended to…
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?
- ExacTrac Dynamic software, Model 20910-01B ETD Positioning and Monitoring Installer 1.0.2 -
- Product Usageintended to position patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures, to monitor the patient position, and to provide a beam hold signal in case of a deviations in order to treat lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated
- Lot codes and dates
Version 1.02GTIN 04056481142315
- Amount recalled
- 22 systems in the U.S.
Where it was sold
Why it was recalled
Display of potential patient movement might be delayed to the user for high dose treatments.
This product could cause temporary or reversible health problems — stop using it.
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