CLASS II Device recall · Reported 6 Dec 2017 · FDA Enforcement Report
Exactrac Vero recalled by Brainlab AG
Brainlab is recalling Exactrac Vero. The recall was initiated on 3 Nov 2017 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-0172-2018
- FDA event ID
- 78488
- Recalling firm
- Brainlab, Munich, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 3 Nov 2017
- FDA classified
- 28 Nov 2017
- Reported
- 6 Dec 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Processing Deviation
- Device type
- Imaging Equipment
Timeline
| 3 Nov 2017 | Recall initiated by company | |
| 28 Nov 2017 | Classified by FDA | +25 days |
| 6 Dec 2017 | 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
Brainlab has internally detected that under specific conditions ExacTrac Vero may not correctly account for this ring angle correction during the calculation of the corresponding couch shift. This may result in the treatment couch not moving to the exact planned position resulting in a deviation between the planned and the treatment target position. This deviation may not be clearly visible to the user if no verification image of the patient position is acquired after this couch shift has been performed.
The USDA issues these when meat or poultry was produced without proper inspection, or when a step such as cooking or pasteurisation did not meet requirements.
Product as listed by the FDA
BRAINLAB EXACTRAC VERO, Model/Catalog Numbers: 46228 EXACTRAC VERO 3.5 46238 EXACTRAC VERO 3.5 46216 EXACTRAC VERO SW UPDATE 3.5.2 TO 3.5.3 46218 EXACTRAC VERO SW UPDATE 3.5.3 TO 3.5.4 The ExacTrac Vero system is intended to be used in conjunction with the MHI-TM2000 Radiation Therapy Linear Accelerator System manufactured by Mitsubishi Heavy Industries, Ltd. ExacTrac Vero uses the images received from the MHI-TM2000 linear accelerator for analyzing the current patient position and calculating - when applicable - a necessary correction shift. The correction shift is then exported to the MHI-TM2000 linear accelerator. The ExacTrac Vero system uses stereoscopic X-ray or Cone Beam CT registration and optical tracking of infrared reflective markers in order to localize and correct the patient position before and during treatment. Optionally ExacTrac Vero provides position data for the pan/tilt motion of the MHI-TM2000 gantry head to the MHITM2000 controller for continuous alignment of the beam orientation with a moving target. The position data is based on target detection via X-ray imaging and IR tracking of external surrogate markers.
Where it was distributed
Worldwide Distribution - US Distribution and to the countries of : Belgium, Canada, France, Germany, Italy, Japan and S. Korea
Questions about this recall
Why was it recalled?
Brainlab has internally detected that under specific conditions ExacTrac Vero may not correctly account for this ring angle correction during the calculation of the corresponding couch shift. This may result in the treatment couch not moving to the exact planned position resulting in a deviation between the planned and the treatment target position. This deviation may not be clearly visible to the user if no verification image of the patient position is acquired after this couch shift has been performed.
Which lots are affected?
Potentially affected are ExacTrac Vero versions 3.x. Currently only ExacTrac Vero SW versions 3.5(.x) are installed for use on existing ExacTrac Vero Systems (only ExacTrac Vero v.3.5 exist in the field). UDI: 04056481132446
Where was it sold?
Worldwide Distribution - US Distribution and to the countries of : Belgium, Canada, France, Germany, Italy, Japan and S. Korea
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 |
| Device | CLASS II | Cirq Arm System recalled by Brainlab AG | Brainlab | Potency & Assay | TX |
| 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 |
Other Imaging Equipment recalls
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| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |