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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 82601

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
March 11, 2019
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Brainlab AG

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

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Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-1205-2019
Recall number
Z-1205-2019
Initiated
March 11, 2019
Classification
Class II
Status
Terminated
Recalling firm
Brainlab AG
Quantity
US - 164 units; Outside the US - 333

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
incorrect dose distribution calculation by Brainlab RT Elements software

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

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Inspect official wording and provenance

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.

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

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.

Field note

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