BRAINLAB; FRAMELESS SRS QA TARGET POINTER Robotics is a device used to compensate rotational patient misalignment (roll

FDA device recall Z-2083-2013 · posted 2013-08-26 · Terminated

Recall details

Recalling firm

Brainlab AG

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.

Action taken

BrainLab sent an "FIELD SAFETY NOTICE / PRODUCT NOTIFICATION" dated July 9, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to discontinue use of the SRS QA Target Pointer. Consignees can instead use the Phantom Pointer feature until Brainlab can provide replacement hardware. Brainlab anticipates being able to provide all impacted facilities with replacement hardware by the end of July 2013. We sincerely apologize for any inconvenience and thank you in advance for your co-operation. If you require further clarification, please feel free to contact your local Brainlab Customer Support Representative. Customer Hotline: +49 89 99 15 68 44 or +1 800 597 5911 (for US customers) or by E-mail: support@brainlab.com. Fax Brainlab AG: + 49 89 99 15 68 33

Root cause

Device Design

Status

Terminated

Product code

IYE

Quantity affected

6 units

Distribution

Worldwide Distribution - US Distribution only to AR., and the countries of Australia, Germany and Japan.

Date initiated

2013-07-16

Date posted

2013-08-26

Date terminated

2017-03-13

Location

Feldkirchen, Germany

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