BrainLAB's VectorVision spine is intended for use as an… — Class II medical device recall Z-0967-2014
Terminated recall by Brainlab AG, reported 2014-02-19, distributed in CA, DC, MN, NC, NY, OH, TX. Brainlab has determined that pins of thee Instrument Star Unit ML (Calibration with ICM4) with specific serial
| Recall number | Z-0967-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Brainlab AG, Feldkirchen, N/A, Germany |
| Recall initiated | 2013-11-15 |
| Classified | 2014-02-10 |
| Reported by FDA | 2014-02-19 |
| Terminated | 2017-03-13 |
| Distributed | CA, DC, MN, NC, NY, OH, TX |
| Countries outside the US | AE, AU, CL, DE, HU, IT, PA, QA, RU, TH |
| Quantity | 25 units |
| Serial numbers | 1205112004, 1205112006, 1205112007, 1205112008, 1205112009, 1205112010, 1205112011, 1205112013, 1205112014, 1205112015, 1205112016, 1205112017, 1205112018, 1205112019, 1205112020, 1205112021, 1205112023, 1205112025, 1205112026, 1205112027, 1205112029, 1205112030, 1205112032, 1205112034, 1205112045 |
| Model numbers | 55830-25A |
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.
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0967-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.