Z-0647-2016Class II

RT Elements are applications for radiation treatment planning for use in stereotactic, conformal, computer...

Name: Z-0647-2016 RT Elements are applications for radiation treatment planning for use in stereotactic, conformal, computer...
Creator: Brainlab AG
Published: 2015-11-05
License: https://open.fda.gov/license/

Brainlab, Inc. / initiated 2015-11-05 / Terminated / root cause: software

FDA source

Brainlab AG began a recall of RT Elements are applications for radiation treatment planning for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial... on 2015-11-05. FDA classified it as Class II and gives the reason as "Large objects with fine resolution are potentially displayed cropped when imported into Brainlab Brain Metastases 1.0.0". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0647-2016
Classification: Class II
Status: Terminated
Initiated: 2015-11-05
Posted: 2016-01-14
Terminated: 2017-08-21
Recalling firm: Brainlab, Inc.
Product: 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. The simulated plan is intended for treatment evaluation for example in tumor board meetings or operating rooms
Product code: MUJ System, Planning, Radiation Therapy Treatment
Reason for recall: Large objects with fine resolution are potentially displayed cropped when imported into Brainlab Brain Metastases 1.0.0.
Root cause tag: software
FDA root cause: Software design
Action: Brainlab sent a FIELD SAFETY NOTICE / PRODUCT NOTIFICATION letter dated November 5, 2015, to all direct accounts informing the of the recall and actions to be taken. User Corrective Action: Users of Brain Metastases Version 1.0.0 or Adaptive Hybrid Surgery Analysis 1.0.0 shall adhere to the following: After import always carefully review and verify all objects for correctness and validity. For reviewing an object, select the image set which was used to outline or to modify the objects in the Data menu. Also compare the contours of an object in Brain Metastases or Adaptive Hybrid Surgery Analysis software to the contours in SmartBrush. Please note that the error will not be visible in SmartBrush. Always verify the correct shape of the objects in Brain Metastases or Adaptive Hybrid Surgery Analysis software. If possible do not use image data sets with large slice distance and/or with a low amount of slices. To retrospectively identify if cropped objects have been used for treatment planning, the object contours of a specific treatment plan can be reviewed in Brainlab Dose Review, where the error will also be visible. Brainlab will provide a software update with this issue solved to affected customers. Brainlab will actively contact affected customers tentatively starting February 2016 to schedule the update. The request that users advise the appropriate personnel working in their department of the content of the Notification letter. If the user facilities require further clarification, thay can contact their local Brainlab Customer Support Representative. Customer Hotline: +49 89 99 15 68 44 or +1 800 597 5911 (for US customers) E-mail: [email protected] (for US customers: [email protected]) Fax: Brainlab AG: + 49 89 99 15 68 33
Quantity in commerce: 20 systems
Distribution: Worldwide Distribution - US (nationwide) and Internationally to Australia, Belgium, Brazil, Canada, China, France, Germany, Hong Kong, Ireland, Israel, Italy, Japan, Mexico, Portugal, South Korea, Spain, Switzerland, Turkey and the United Kingdom.
Product codes and lots: Brain Metastases version 1.0.0 Model/catalogue number Description 21702-04 ELEMENTS AUT. BRAIN METASTASES PLAN INST 21703-01 ELEMENTS ADAPT HYB SURG ANALYSIS LICENSE 21703-02 ELEMENTS ADAPT HYB SURG ANALYSIS INST 21702 ELEMENTS AUTOMATIC BRAIN METS PLAN SUB 21702-12 ELEMENTS AUTOMATIC BRAIN METS PLAN SUB 21702-36 ELEMENTS AUTOMATIC BRAIN METS PLAN SUB 21702-60 ELEMENTS AUTOMATIC BRAIN METS PLAN SUB 21703 ELEMENTS AD-HYBRID SURG ANALYSIS SUBSCR 21703-12 ELEMENTS AD-HYBRID SURG ANALYSIS SUBSCR 21703-36 ELEMENTS AD-HYBRID SURG ANALYSIS SUBSCR 21703-60 ELEMENTS AD-HYBRID SURG ANALYSIS SUBSCR 21713 ELEMENTS ADAPTIVE HYBRID SURG. ANALYSIS 21722 ELEMENTS AUTO. BRAIN MET PLAN SUBS. FOC 21722-12 ELEMENTS AUTO. BRAIN MET PLAN SUBS. FOC 21722-36 ELEMENTS AUTO. BRAIN MET PLAN SUBS. FOC 21722-60 ELEMENTS AUTO. BRAIN MET PLAN SUBS. FOC 21723 ELEMENTS ADAPT HYB SURG ANALYS SUBS. FOC 21723-12 ELEMENTS ADAPT HYB SURG ANALYS SUBS. FOC 21723-36 ELEMENTS ADAPT HYB SURG ANALYS SUBS. FOC 21723-60 ELEMENTS ADAPT HYB SURG ANALYS SUBS. FOC 21732 ELEMENTS AUTOMATIC BRAIN METS PLAN. 12M

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0647-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0647-2016	Class II	Terminated	Voluntary: Firm initiated	2016-01-20	2016-01-14
Z-0648-2016	Class II	Terminated	Voluntary: Firm initiated	2016-01-20	2016-01-14

Product code MUJ

K142108Class IIRt Elements, Dose Review, Brain Metastases, Adaptive Hybrid Surgery AnalysisBrainlab AG / cleared 2014-12-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)