Z-0967-2014Class II

BrainLAB's VectorVision spine is intended for use as an intraoperative image-guided localization system for...

Name: Z-0967-2014 BrainLAB's VectorVision spine is intended for use as an intraoperative image-guided localization system for...
Creator: Brainlab AG
Published: 2013-11-15
License: https://open.fda.gov/license/

Brainlab, Inc. / initiated 2013-11-15 / Terminated / root cause: manufacturing process

FDA source

Brainlab AG began a recall of BrainLAB's VectorVision spine is intended for use as an intraoperative image-guided localization system for minimally invasive surgery. It links a freehand... on 2013-11-15. FDA classified it as Class II and gives the reason as "Brainlab has determined that pins of thee Instrument Star Unit ML (Calibration with ICM4) with specific serial numbers might have been made of an incorrect material that is not suitable for the necessary disinfection...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0967-2014
Classification: Class II
Status: Terminated
Initiated: 2013-11-15
Posted: 2014-02-10
Terminated: 2017-03-13
Recalling firm: Brainlab, Inc.
Product: BrainLAB's VectorVision spine is intended for use as an intraoperative image-guided localization system for minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on a patient's preoperative image data that is processed by a VectorVision workstation. The system is indicated for any medical condition in which the use of stereoscopic surgery may be appropriate and where a reference to a rigid anatomical structure, such as the skull, the pelvis, a long bone or vertebra can be identified relative to a CT, x-ray, or MR-based model of the anatomy.
Product code: HAW Neurological Stereotaxic Instrument
Reason for recall: Brainlab has determined that pins of thee Instrument Star Unit ML (Calibration with ICM4) with specific serial numbers might have been made of an incorrect material that is not suitable for the necessary disinfection and sterilization of the product. If corrosion occurs and is not detected by the user, and the device is used during surgery, corroded particles of the pin could, directly or indirect
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: BrainLab send a A FIELD SAFETY NOTICE / PRODUCT NOTIFICATION letter dated November 15, 2013, to all affected customers. The letter requested that customers verify that they are in possession of one or more of the affected devices, remove the affected devices from use, and that Brainlab will provide replacement parts for the customers. Customers with questions can contact Brainlab by telephone at 1-800-597-5911 or via e-mail at [email protected]. For questions regarding this recall call 800-597-5911.
Quantity in commerce: 25 units
Distribution: Worldwide Distribution - USA including CA, MN, NC, NY, OH, TX and DC. Internationally to Australia, Chile, Germany, Hungary, Italy, Panama, Qatar, Russia, Thailand, United Arab Emirates.
Product codes and lots: Model/Catalog Code: 55830-25A Instrument Star Unit ML; Serial Numbers (US Devices): 1205112007, 1205112010, 1205112011, 1205112013, 1205112014, 1205112019, 1205112021, 1205112029, 1205112034, 1205112045; Serial Numbers (Non-US Devices): 1205112004, 1205112006, 1205112008, 1205112009, 1205112015, 1205112016, 1205112017, 1205112018, 1205112020, 1205112023, 1205112025, 1205112026, 1205112027, 1205112030, 1205112032

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0967-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0967-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-19	2014-02-10

Product code HAW

K053159Class IIVectorvision SpineBrainlab AG / cleared 2006-06-06

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)