CLASS II ONGOING Device recall · Reported 16 Mar 2022 · FDA Enforcement Report
ExacTrac Dynamic recalled by Brainlab AG
Brainlab is recalling ExacTrac Dynamic, distributed in 20 states. The recall was initiated on 25 Feb 2022 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-0733-2022
- FDA event ID
- 89662
- Recalling firm
- Brainlab, Munich, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 25 Feb 2022
- FDA classified
- 8 Mar 2022
- Reported
- 16 Mar 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Device Malfunction
- Device type
- Medical Software
Timeline
| 25 Feb 2022 | Recall initiated by company | |
| 8 Mar 2022 | Classified by FDA | +11 days |
| 16 Mar 2022 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The yaw angle may be incorrect for CBCT positioning workflows using setup beams with Varian LINACs.
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 software model numbers: 20910-01, ETD Positioning and Moni. 1.0.0 INST; 20910-01A, ETD Positioning and Moni. 1.0.1 INST; 20910-01B, ETD Positioning and Moni. 1.0.2 INST; and 20910-01C ETD Positioning and Moni. 1.0.3 INST.
Where it was distributed
Distribution was made to AZ, AR, CA, CO, FL, GA, IN, KY, MD, MS, MO, NJ, NY, NC, OK, OR, PA, TX, VA, and WA. There was no government or military distribution. Foreign distribution was made to Australia, Austria, Bahrain, Belgium, China, Denmark, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Japan, Jordan, New Zealand, Poland, Singapore, Slovakia, South Korea, Spain, Thailand, Turkey, United Kingdom, and United Arab Emirates.
ArkansasArizonaCaliforniaColoradoFloridaGeorgiaIndianaKentuckyMarylandMissouriMississippiNorth CarolinaNew JerseyNew YorkOklahomaOregonPennsylvaniaTexasVirginiaWashington
Questions about this recall
Why was it recalled?
The yaw angle may be incorrect for CBCT positioning workflows using setup beams with Varian LINACs.
Which lots are affected?
Software versions 1.0.0, 1.0.1, 1.0.2, 1.0.3, GTIN 04056481142315.
Where was it sold?
Distribution was made to AZ, AR, CA, CO, FL, GA, IN, KY, MD, MS, MO, NJ, NY, NC, OK, OR, PA, TX, VA, and WA. There was no government or military distribution. Foreign distribution was made to Australia, Austria, Bahrain, Belgium, China, Denmark, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Japan, Jordan, New Zealand, Poland, Singapore, Slovakia, South Korea, Spain, Thailand, Turkey, United Kingdom, and 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 | ExacTrac Dynamic recalled by Brainlab AG | Brainlab | Device Malfunction | Nationwide |
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