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.

The yaw angle may be incorrect for CBCT positioning workflows using setup beams with Varian LINACs.

Recall #: Z-0733-2022
Affected scope: 205 systems
Initiated: February 25, 2022

Compiled from official public sources by the publisher. · Updated September 2026

Brainlab Ag recalled ExacTrac Dynamic software model numbers: 20910-01, ETD Positioning and Moni. 1.0.0 INS… - a moderate-severity action.

ExacTrac Dynamic software model numbers: 20910-01, ETD Positioning and Moni. 1.0.0 INS… was recalled by Brainlab Ag in March 16, 2022. Reason: The yaw angle may be incorrect for CBCT positioning workflows using setup beams with Varian LINACs.. Check the official notice for the remedy. Verify recall #Z-0733-2022 with the FDA Devices before acting.

The recall

Brainlab Ag issued this moderate-severity FDA Devices recall-The yaw angle may be incorrect for CBCT positioning workflows using setup beams with Varian LINACs..

Moderate
severity level: Class II
classification: March 16, 2022
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-0733-2022 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) 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, 6 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.

Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. 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.

Product description

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.

Reason for recall

The yaw angle may be incorrect for CBCT positioning workflows using setup beams with Varian LINACs.

Recall Profile

Structured summary of the FDA Devices recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Moderate (Class II)
Status	Ongoing
Recall number	Z-0733-2022
Date reported	March 16, 2022
Date initiated	February 25, 2022
Recalling firm	Brainlab Ag
Firm location	Munich, N/A
Affected scope	205 systems
Distribution	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, …

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-0733-2022) 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? ▼

Why was this product recalled? ▼

The yaw angle may be incorrect for CBCT positioning workflows using setup beams with Varian LINACs.

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on March 16, 2022. Severity: Moderate. Recall number: Z-0733-2022.

Where was the recalled product distributed? ▼

Distribution: 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..

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.

Nationwide recalls with similar severity or category timing

Drug and device notices outside this firm and state, matched by severity timing and product category.

Similar severity · nearest report date

Same archive severity grade (Moderate), closest by report date among other firms and states.

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Similar Medical Devices · nearest report date

Same product category, closest by report date among other firms and states (deduped against the severity set).

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This recall: FDA Devices, reported March 16, 2022. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026