Brainlab Frameless SRS QA Target Pointer Cap Recall
Brainlab AG is recalling 6 units of the Frameless SRS QA Target Pointer because the pointer cap may become loose under moderate force.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a mechanical defect (loose cap) without reported injuries or illnesses, fitting the criteria for a moderate severity recall.
Plain-English summary
Brainlab AG is recalling 6 units of the Frameless SRS QA Target Pointer, Part No. 43410. The device is used to compensate for rotational patient misalignment in a linear accelerator environment for stereotactic radiosurgery or radiotherapy procedures.
The recall is due to a defect where the pointer cap with engraved crosshairs may become loose even when only moderate force is applied. This issue could affect the accuracy of the device during quality assurance procedures.
The affected units were distributed worldwide, with US distribution limited to Arkansas, and also shipped to Australia, Germany, and Japan. Users should stop using the affected pointer caps and contact Brainlab AG for further instructions.
The recalled product
- 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 u
- Manufacturer
- Brainlab AG
- Hazard
- Affected units
- 6
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Part No. 43410
Distribution
Distributed in 1 state:
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