RT Elements Software revisions of the RT Elements recall: Software Issue
RT Elements Software revisions of the RT Elements applications have a specific software version number. Specifically the following RT Elements…
Why was RT Elements Software revisions of the RT Elements recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- RT Elements Software revisions of the RT Elements applications have a specific software version number. Specifically the following RT Elements…
- Recalling firm
- Brainlab AG
- Quantity
- US - 164 units; Outside the US - 333
- Distribution
- 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.
- Recall date
- May 1, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)