ExacTrac Dynamic software recall
ExacTrac Dynamic software, Model 20910-01B ETD Positioning and Monitoring Installer 1.0.2 - Product Usage: intended to position patients at an…
Why was ExacTrac Dynamic software recalled?
Display of potential patient movement might be delayed to the user for high dose treatments.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Version 1.02, GTIN 04056481142315
- Product
- ExacTrac Dynamic software, Model 20910-01B ETD Positioning and Monitoring Installer 1.0.2 - Product Usage: intended to position patients at an…
- Recalling firm
- Brainlab AG
- Quantity
- 22 systems in the U.S.
- Distribution
- US Nationwide distribution in the states of AZ, AR, CA, FL, IN, NJ, NY, NC, OR, PA, and TX. There was no government/military distribution.
- Recall date
- June 16, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)