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RT Elements Software revisions of the RT Elements applications have a specific software version...

FDA Device Recall #Z-1205-2019 — Class II — March 11, 2019

Recall Summary

Recall Number Z-1205-2019
Classification Class II — Moderate risk
Date Initiated March 11, 2019
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Brainlab AG
Location Munich, N/A
Product Type Devices
Quantity US - 164 units; Outside the US - 333

Product Description

RT Elements Software revisions of the RT Elements applications have a specific software version number. Specifically the following RT Elements applications/versions are affected: - Cranial SRS 1.0.0 and 1.5.0 - Spine SRS 1.0.0 and 1.5.0 - Multiple Brain Mets SRS 1.5.0 - RT QA 1.0.0 and 1.5.0 Product Usage: The RT Elements are applications for radiation treatment planning for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck and extracranial lesions.

Reason for Recall

There is a potential for an incorrect dose distribution calculation by Brainlab RT Elements software (for affected versions) under specific circumstances when using the Pencil Beam algorithm on the GPU (graphics card), as is the default system setting.

Distribution Pattern

Worldwide Distribution - US Nationwide in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IN, KY, LA, MA, MD, MS, NC, NJ, NY, OH, OR, PA, SC, TN, TX, UT, VA, & WV. Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Colombia, El Salvador, Finland, France, Germany, Hong Kong, Iran, Ireland, Israel, Italy, Japan, Jordan, Lebanon, Martinique, Mexico, Monaco, Morocco, Netherlands, Poland, Portugal, Russian Fed., South Africa, South Korea, Spain, Switzerland, Taiwan, Tunisia, United Arab Emirates, and United Kingdom.

Lot / Code Information

Software revisions of affected RT Elements applications: - Cranial SRS 1.0.0 and 1.5.0 - Spine SRS 1.0.0 and 1.5.0 - Multiple Brain Mets SRS 1.5.0 - RT QA 1.0.0 and 1.5.0 Unique Identifier (UDI): GTIN for affected product(s): Cranial SRS 1.0 -7 04056481000554 Cranial SRS 1.5 -704056481140403 Spine SRS 1.0 - 04056481000547 Spine SRS 1.5 - 04056481140380 Multiple Brain Mets SRS 1.5 7 04056481006853 RT QA 1.0 -7 04056481007119 RT QA 1.5 -7 04056481140397 Model/catalogue numbers: 21702A ELEMENTS MULTIPLE BRAIN METS SRS SUB. 21702-04C ELEMENTS MULTIPLE BRAIN METS SRS INST 21702-0 6 ELEMENTS MULTIPLE BRAIN METS SRS LICENSE 21702-12A ELEMENTS MULTIPLE BRAIN METS SRS SUB. 21702-36A ELEMENTS MULTIPLE BRAIN METS SRS SUB. 21702-60A ELEMENTS MULTIPLE BRAIN METS SRS SUB. 21712A ELEMENTS MULTIPLE BRAIN METS SRS 21722A ELEMENTS MULTIPLE BRAIN METS SRS SUB FOC 21722-12A ELEMENTS MULTIPLE BRAIN METS SRS SUB FOC 21741A UPD TO ELEMENTS BRAIN MET PLAN 21742 ELEMENTS CRANIAL SRS 21742A ELEMENTS CRANIAL SRS 21743 ELEMENTS CRANIAL SRS SUBSCRIPTION 21743A ELEMENTS CRANIAL SRS SUBSCRIPTION 21743-01 ELEMENTS CRANIAL SRS LICENSE ELEMENTS CRANIAL SRS LICENSE 1.5 ELEMENTS CRANIAL SRS INSTALLER 21743-02A ELEMENTS CRANIAL SRS INSTALLER 1.5 21743-12 ELEMENTS CRANIAL SRS SUBSCRIPTION 21743-36 ELEMENTS CRANIAL SRS SUBSCRIPTION 21743-60 ELEMENTS CRANIAL SRS SUBSCRIPTION 21744 ELEMENTS CRANIAL SRS SUBSCRIPTION FOC 21744A ELEMENTS CRANIAL SRS SUBSCRIPTION FOC 21744-12 ELEMENTS CRANIAL SRS SUBSCRIPTION FOC 21744-36 ELEMENTS CRANIAL SRS SUBSCRIPTION FOC 21744-60 ELEMENTS CRANIAL SRS SUBSCRIPTION FOC 21745 ELEMENTS CRANIAL SRS (UPD) 21745A ELEMENTS CRANIAL SRS (UPD) 21747 ELEMENTS SPINE SRS 21747A ELEMENTS SPINE SRS 21748 ELEMENTS SPINE SRS SUBSCRIPTION 21748A ELEMENTS SPINE SRS SUBSCRIPTION 21748-01 ELEMENTS SPINE SRS LICENSE ELEMENTS SPINE SRS LICENSE 1.5 ELEMENTS SPINE SRS INSTALLER 21748-02A ELEMENTS SPINE SRS INSTALLER 1.5 21748-12 ELEMENTS SPINE SRS SUBSCRIPTION 21748-36 ELEMENTS SPINE SRS SUBSCRIPTION 21748-60 ELEMENTS SPINE SRS SUBSCRIPTION 21749 ELEMENTS SPINE SRS SUBSCRIPTION FOC 21749A ELEMENTS SPINE SRS SUBSCRIPTION FOC 21749-12 ELEMENTS SPINE SRS SUBSCRIPTION FOC 21749-36 ELEMENTS SPINE SRS SUBSCRIPTION FOC 21749-60 ELEMENTS SPINE SRS SUBSCRIPTION FOC 21750 ELEMENTS SPINE SRS (UPD) 21750A ELEMENTS SPINE SRS (UPD) 21762 RT QA 1.0 21762A RT QA 1.5 21762-01 RT QA LICENSE RT QA LICENSE 1.5 RT QA INSTALLER 21762-02A RT QA INSTALLER 1.5

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Frequently Asked Questions

A software recall means the device's embedded software or firmware has a defect that could affect its performance or safety. Many software recalls are corrected through firmware updates that can be applied without physically replacing the device. For implantable devices, the update may be delivered wirelessly during a routine clinic visit. For external devices, the manufacturer may provide updated software files or replacement units. Contact your healthcare provider to determine whether your specific device and software version are affected and what action is recommended.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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