FDAClass IISeptember 4, 2013

Brainlab recall

BRAINLAB; FRAMELESS SRS QA TARGET POINTER Robotics is a device used to compensate rotational patient misalignment (roll and pitch) in a linear…

Why was Brainlab recalled?

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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Part No. 43410

Product
BRAINLAB; FRAMELESS SRS QA TARGET POINTER Robotics is a device used to compensate rotational patient misalignment (roll and pitch) in a linear…
Recalling firm
Brainlab AG
Quantity
6 units
Distribution
Worldwide Distribution - US Distribution only to AR., and the countries of Australia, Germany and Japan.
Recall date
September 4, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
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