CLASS II Device recall · Reported 7 May 2014 · FDA Enforcement Report
ExacTrac 0 is a patient positioning and monitoring system recalled
Brainlab AG is recalling ExacTrac 0 is a patient positioning and monitoring system, distributed in 7 states. The recall was initiated on 24 Feb 2014 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-1513-2014
- FDA event ID
- 67719
- Recalling firm
- Brainlab AG, Feldkirchen
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 24 Feb 2014
- FDA classified
- 25 Apr 2014
- Reported
- 7 May 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Patient Monitors
Timeline
| 24 Feb 2014 | Recall initiated by company | |
| 25 Apr 2014 | Classified by FDA | +60 days |
| 7 May 2014 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
When using multiple radiation treatment targets within a single plan, the ExacTrac v.6.0.3 might position the patient to an unintended radiation treatment point. As a result, there is a possibility that the radiation treatment dose may be delivered to the unintended target position.
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 6.0 is a patient positioning and monitoring system. Model/catalogue numbers: 20833B EXACTRAC 6.0 IR POSITIONING SOFTWARE 49936 ET SOFTWARE UPDATE 6.0.X TO 6.0.3 49926B ET UPGRADE SOFTWARE 3.X TO 6.0 (IR+XR) 49934A EXACTRAC UPGRADE 5.5 TO 6.0 BASIC 49927B ET UPGRADE SOFTWARE 4.X TO 6.0 (IR+XR) 49928B ET UPGRADE SOFTWARE 5.X TO 6.0 (IR+XR) 49933B ET UPGRADE TRUEBEAM 5.5 TO 6.0 LIMITED 49973B ET DATA PREP / REVIEW SYSTEM 49998B ET 6.0 DATA PREP/REVIEW SYSTEM UPG. KIT 49996B ET UPGRADE SOFTWARE X.X TO 6.0 SW ONLY 49997B ET UPGRADE SOFTWARE 5.5 TO 6.0 LIMITED
Where it was distributed
Worldwide Distribution -- USA, including the states of CA, IN, LA, MA, OH, TX, and WI, and the countries of Australia, China, France, Germany, Japan, Netherlands, and the United Kingdom.
CaliforniaIndianaLouisianaMassachusettsOhioTexasWisconsin
Stores named: Target
Questions about this recall
Is ExacTrac 0 is a patient positioning and monitoring system recalled?
Yes. Brainlab AG recalled ExacTrac 0 is a patient positioning and monitoring system on 24 Feb 2014. The recall is Class II and its status is Terminated. Recall number Z-1513-2014.
Why was it recalled?
When using multiple radiation treatment targets within a single plan, the ExacTrac v.6.0.3 might position the patient to an unintended radiation treatment point. As a result, there is a possibility that the radiation treatment dose may be delivered to the unintended target position.
Which lots are affected?
ExacTrac version v.6.0.3.
Where was it sold?
Worldwide Distribution -- USA, including the states of CA, IN, LA, MA, OH, TX, and WI, and the countries of Australia, China, France, Germany, Japan, Netherlands, and the United Kingdom.
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 21 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 AG
All 39| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Origin Data Management recalled by Brainlab AG | Brainlab AG | Device Malfunction | Nationwide |
| Device | CLASS II | Cirq Arm System recalled by Brainlab AG | Brainlab AG | Potency & Assay | TX |
| Device | CLASS II | ExacTrac Dynamic recalled by Brainlab AG | Brainlab AG | Device Malfunction | Nationwide |
| Device | CLASS II | ExacTrac Dynamic recalled by Brainlab AG | Brainlab AG | Device Malfunction | 20 states |
| Device | CLASS II | ExacTrac Dynamic recalled by Brainlab AG | Brainlab AG | Processing Deviation | Nationwide |
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| Device | CLASS I | Bravo CF capsule delivery device, Product Number FGS recalled | Given Imaging | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | IQecg Digital ECG recalled by Midmark | Midmark | Labeling Errors | Nationwide |