CIVCO General Purpose Sensor, Non-sterile reusable general purpose electromagnetic sensor, for us...
FDA Device Recall #Z-1955-2012 — Class II — May 7, 2012
Recall Summary
| Recall Number | Z-1955-2012 |
| Classification | Class II — Moderate risk |
| Date Initiated | May 7, 2012 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Civco Medical Instruments Inc |
| Location | Kalona, IA |
| Product Type | Devices |
| Quantity | 9 kits |
Product Description
CIVCO General Purpose Sensor, Non-sterile reusable general purpose electromagnetic sensor, for use with 3D Guidance medSAFE trackers, Ref. 610-1067. The firm name on the label is CIVCO, Kalona, IA. The kit contains sensor component part number 410-240. The general purpose sensor within the kit is intended to provide physicians with tools for electromagnetic tracking of instruments with respect to image data. The sensors are designed to attach to custom reusable tracking bracket for leading transducers and other medical devices
Reason for Recall
The general purpose electromagnetic sensor was incorrectly calibrated causing potential variability in the projected position of the needle path with the ultrasound device.
Distribution Pattern
Worldwide Distribution - USA including WI, CA, MA, IN, WA, and NJ. Foreign distribution was made to Germany, Canada, Denmark, Hong Kong, Ukraine, Japan, Italy, Korea, and France.
Lot / Code Information
Lot number M713910
Other Recalls from Civco Medical Instruments Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1400-2015 | Class II | CIVCO Surgi-Tip Transducer Cover Sterile (15.2 ... | Feb 26, 2015 |
| Z-2558-2014 | Class II | CollectEVAC, Sterile device with tubing and ada... | Aug 1, 2014 |
| Z-0802-2014 | Class II | Civco Belly Board, Reusable non-sterile carbon ... | Oct 25, 2013 |
| Z-0803-2014 | Class II | Civco Belly Board MRI, Reusable non-sterile gla... | Oct 25, 2013 |
| Z-1956-2012 | Class II | CIVCO VirtuTRAX Instrument Navigator, Reusable ... | May 7, 2012 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
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.