FDA Device recall Z-0647-2016
RT Elements are applications for radiation treatment planning for use in stereotactic, conformal, computer planned, Linac based radiation t…
- FDA Device
- Class II
- terminated
- Published 2016-01-20
On 2016-01-20 the FDA classified a Class II recall of RT Elements are applications for radiation treatment planning for use in stereotactic, conformal, computer planned, Linac based radiation t… by Brainlab Ag, citing large objects with fine resolution are potentially displayed cropped when imported into Brainlab Brain Metastases 1.0.0.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0647-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-11-05 |
| Published | 2016-01-20 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Brainlab Ag |
| Distribution | US |
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
Reason
Large objects with fine resolution are potentially displayed cropped when imported into Brainlab Brain Metastases 1.0.0.
Identifiers
| code_info | Brain Metastases version 1.0.0 Model/catalogue number Description 21702-04 ELEMENTS AUT.…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0647-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.