CLASS II Device recall · Reported 17 Mar 2021 · FDA Enforcement Report
ExacTrac Dynamic (Medical Charged-Particle Radiation Therapy System) recalled
Brainlab is recalling ExacTrac Dynamic (Medical Charged-Particle Radiation Therapy System), distributed in 8 states. The recall was initiated on 1 Mar 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1185-2021
- FDA event ID
- 87395
- Recalling firm
- Brainlab, Munich
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 1 Mar 2021
- FDA classified
- 8 Mar 2021
- Reported
- 17 Mar 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 1 Mar 2021 | Recall initiated by company | |
| 8 Mar 2021 | Classified by FDA | +7 days |
| 17 Mar 2021 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
In case of a failed automatic marker detection, a software error causes parts of the display to incorrectly behave as if the current patient position is within predefined tolerances and may allow the user to proceed to treatment despite potentially exceeding shift values.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
ExacTrac Dynamic (Medical Charged-Particle Radiation Therapy System).
Where it was distributed
USA: (CA, NJ, AZ, AR, NY, IN, OR, NC), Australia, Austria, Belgium, Denmark, France, Germany, Hong Kong, Italy, Slovakia, Spain, Thailand, Turkey, United Kingdom, United Arab Emirates.
ArkansasArizonaCaliforniaIndianaNorth CarolinaNew JerseyNew YorkOregon
Questions about this recall
Why was it recalled?
In case of a failed automatic marker detection, a software error causes parts of the display to incorrectly behave as if the current patient position is within predefined tolerances and may allow the user to proceed to treatment despite potentially exceeding shift values.
Which lots are affected?
Model/catalogue numbers: 20910-06 ETD Implanted lic. UDI: The GTIN for ExacTrac Dynamic version 1.0 is 04056481142315. GMDN code: 40887. Software revisions of affected ExacTrac Dynamic software: versions 1.0.0, 1.0.1, 1.0.2.
Where was it sold?
USA: (CA, NJ, AZ, AR, NY, IN, OR, NC), Australia, Austria, Belgium, Denmark, France, Germany, Hong Kong, Italy, Slovakia, Spain, Thailand, Turkey, United Kingdom, United Arab Emirates.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Brainlab
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|---|---|---|---|---|---|
| Device | CLASS II | Origin Data Management recalled by Brainlab AG | Brainlab | Device Malfunction | Nationwide |
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| Device | CLASS II | ExacTrac Dynamic recalled by Brainlab AG | Brainlab | Device Malfunction | Nationwide |
| Device | CLASS II | ExacTrac Dynamic recalled by Brainlab AG | Brainlab | Device Malfunction | 20 states |
| Device | CLASS II | ExacTrac Dynamic recalled by Brainlab AG | Brainlab | Processing Deviation | Nationwide |
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