BrainLAB's VectorVision spine is intended for use as an intraoperative image-guided localization ...
FDA Device Recall #Z-0967-2014 — Class II — November 15, 2013
Recall Summary
| Recall Number | Z-0967-2014 |
| Classification | Class II — Moderate risk |
| Date Initiated | November 15, 2013 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Brainlab AG |
| Location | Feldkirchen, N/A |
| Product Type | Devices |
| Quantity | 25 units |
Product Description
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
Distribution Pattern
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.
Lot / Code Information
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
Other Recalls from Brainlab AG
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1392-2025 | Class II | Origin Data Management software versions 3.1.0,... | Feb 10, 2025 |
| Z-1292-2023 | Class II | Cirq Arm System 2.0 | Mar 2, 2023 |
| Z-1259-2023 | Class II | Brainlab ExacTrac Dynamic software, Medical Cha... | Feb 14, 2023 |
| Z-0733-2022 | Class II | ExacTrac Dynamic software model numbers: 209... | Feb 25, 2022 |
| Z-1846-2021 | Class II | ExacTrac Dynamic software, Model 20910-01B ETD ... | May 14, 2021 |
Frequently Asked Questions
Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.