Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported August 13, 2014
ExacTrac is intended to be used to place patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures, in order to treat lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. ExacTrac may also be used to monitor the patient position during the treatment.
When using multiple isocenters (radiation treatment targets) within a single plan, in certain workflow conditions ExacTrac v.6.0.4 might move the patient to an unintended isocente…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Brainlab Ag recalled ExacTrac is intended to be used to place patients at an accurately defined point within t… - a moderate-severity action.
ExacTrac is intended to be used to place patients at an accurately defined point within t… was recalled by Brainlab Ag in August 13, 2014. Reason: When using multiple isocenters (radiation treatment targets) within a single plan, in certain workflow condit…. Check the official notice for the remedy. Verify recall #Z-2146-2014 with the FDA Devices before acting.
The recall
Brainlab Ag issued this moderate-severity FDA Devices recall-When using multiple isocenters (radiation treatment targets) within a single plan, in certain workflow condit….
- Moderate
- severity level
- Class II
- classification
- August 13, 2014
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2146-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2146-2014) was formally reported on August 13, 2014, with the manufacturer initiating the action on June 24, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. Brainlab Ag is listed as the recalling firm, operating out of Feldkirchen, N/A. Federal records list the affected scope as 15 systems.
The documented reason for this recall is: When using multiple isocenters (radiation treatment targets) within a single plan, in certain workflow conditions ExacTrac v.6.0.4 might move the patient to an unintended isocenter position, despite displaying the green… Distribution data in the federal record shows the product reached: Worldwide Distribution - USA including CA, CT, and IL; Internationally to France, Germany, Japan, Netherlands, Russia, and Slovenia.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
15 systems
Related Recalls
6
3 from same agency
Product description
ExacTrac is intended to be used to place patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures, in order to treat lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. ExacTrac may also be used to monitor the patient position during the treatment.
Reason for recall
When using multiple isocenters (radiation treatment targets) within a single plan, in certain workflow conditions ExacTrac v.6.0.4 might move the patient to an unintended isocenter position, despite displaying the green "OK" icon. If this anomaly occurs and is not detected by the user, the radiation treatment dose at the linear accelerator may be delivered to the unintended target position.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2146-2014 |
| Date reported | August 13, 2014 |
| Date initiated | June 24, 2014 |
| Recalling firm | Brainlab Ag |
| Firm location | Feldkirchen, N/A |
| Affected scope | 15 systems |
| Distribution | Worldwide Distribution - USA including CA, CT, and IL; Internationally to France, Germany, Japan, Netherlands, Russia, and Slovenia. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2146-2014) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
ExacTrac is intended to be used to place patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures, in order to treat lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. ExacTrac may also be used to monitor the patient position during the treatment.. Recalled by Brainlab Ag. Units affected: 15 systems.
Why was this product recalled? ▼
When using multiple isocenters (radiation treatment targets) within a single plan, in certain workflow conditions ExacTrac v.6.0.4 might move the patient to an unintended isocenter position, despite displaying the green "OK" icon. If this anomaly occurs and is not detected by the user, the radiation treatment dose at the linear accelerator may be delivered to the unintended target position.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 13, 2014. Severity: Moderate. Recall number: Z-2146-2014.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - USA including CA, CT, and IL; Internationally to France, Germany, Japan, Netherlands, Russia, and Slovenia..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2146-2014) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported August 13, 2014. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.