CLASS II Device recall · Reported 20 Jan 2016 · FDA Enforcement Report
RT Elements are applications recalled by Brainlab AG
Brainlab AG is recalling RT Elements are applications for radiation treatment planning for use in stereotactic, distributed nationwide in the US. The recall was initiated on 5 Nov 2015 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0647-2016
- FDA event ID
- 72804
- Recalling firm
- Brainlab AG, Feldkirchen, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 5 Nov 2015
- FDA classified
- 14 Jan 2016
- Reported
- 20 Jan 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 5 Nov 2015 | Recall initiated by company | |
| 14 Jan 2016 | Classified by FDA | +70 days |
| 20 Jan 2016 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Large objects with fine resolution are potentially displayed cropped when imported into Brainlab Brain Metastases 1.0.0.
Product as listed by the FDA
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
Where it was distributed
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.
Questions about this recall
Is RT Elements are applications for radiation treatment planning for use in stereotactic recalled?
Yes. Brainlab AG recalled RT Elements are applications for radiation treatment planning for use in stereotactic on 5 Nov 2015. The recall is Class II and its status is Terminated. Recall number Z-0647-2016.
Why was it recalled?
Large objects with fine resolution are potentially displayed cropped when imported into Brainlab Brain Metastases 1.0.0.
Which lots are affected?
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
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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