Z-2083-2013Class II

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

Name: Z-2083-2013 BRAINLAB; FRAMELESS SRS QA TARGET POINTER Robotics is a device used to compensate rotational patient...
Creator: Brainlab AG
Published: 2013-07-16
License: https://open.fda.gov/license/

Brainlab, Inc. / initiated 2013-07-16 / Terminated / root cause: design

FDA source

Brainlab AG began a recall of BRAINLAB; FRAMELESS SRS QA TARGET POINTER Robotics is a device used to compensate rotational patient misalignment (roll and pitch) in a linear accelerator... on 2013-07-16. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2083-2013
Classification: Class II
Status: Terminated
Initiated: 2013-07-16
Posted: 2013-08-26
Terminated: 2017-03-13
Recalling firm: Brainlab, Inc.
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.
Product code: IYE Accelerator, Linear, Medical
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.
Root cause tag: design
FDA root cause: Device Design
Action: 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: [email protected]. Fax Brainlab AG: + 49 89 99 15 68 33
Quantity in commerce: 6 units
Distribution: Worldwide Distribution - US Distribution only to AR., and the countries of Australia, Germany and Japan.
Product codes and lots: Part No. 43410

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2083-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2083-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-04	2013-08-26

Product code IYE

K073018Class IIStereotactic Target Positioner, Target Positioner for Leksell Headring, Stereotactic CounterweightBrainlab AG / cleared 2008-01-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)