BRAINLAB — Class II medical device recall Z-2083-2013
Terminated recall by Brainlab AG, reported 2013-09-04, distributed in AR. The Frameless SRS QA Target Pointer - Pointer Cap with the engraved cross hairs may become loose even when onl
| Recall number | Z-2083-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Brainlab AG, Feldkirchen, Germany |
| Recall initiated | 2013-07-16 |
| Classified | 2013-08-26 |
| Reported by FDA | 2013-09-04 |
| Terminated | 2017-03-13 |
| Distributed | AR |
| Countries outside the US | AU, DE, JP |
| Quantity | 6 units |
| Model numbers | 43410 |
Product
BRAINLAB; FRAMELESS SRS QA TARGET POINTER Robotics is a device used to compensate rotational patient misalignment (roll and pitch) in a linear accelerator environment for stereotactic radiosurgery or radiotherapy procedures. The Frameless Radiosurgery Components are a device used for fixation, localization and repositioning of the patient's: head and neck; and head, neck, and shoulders, in a linear accelerator environment for stereotactic radiosurgery/radiotherapy procedures.
Reason for recall
The Frameless SRS QA Target Pointer - Pointer Cap with the engraved cross hairs may become loose even when only a moderate force is applied to the Pointer Cap.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2083-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.