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omniTRAX Patient Tracker Starter Kit
CIVCO MEDICAL INSTRUMENTS CO., INC. · Model 5438658 · UDI-DI 00841436101042
IYO
Prescription
1
510(k) clearances
6,553
Adverse events (17 deaths)
83
Recalls
352
Facilities
Description
Reusable non-sterile multi-modality fiducial markers (5), reusable non-sterile general purpose electromagnetic sensor for use with 3D Guidance driveBAY™, driveBAY™ 2™, trakSTAR™ or trakSTAR™ 2 trackers
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-08-06 | Volcano Corp | Software system may associate image data from one patient with another patient's record, potentially resulting in incorrect diagnosis or treatment. |
| 2026-03-02 | Civco Medical Instruments Co. Inc. | There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified |
| 2026-03-02 | Civco Medical Instruments Co. Inc. | There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified |
| 2026-03-02 | Civco Medical Instruments Co. Inc. | There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified |
| 2026-03-02 | Civco Medical Instruments Co. Inc. | There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified |
| 2026-03-02 | Civco Medical Instruments Co. Inc. | There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified |
| 2026-03-02 | Civco Medical Instruments Co. Inc. | There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified |
| 2026-03-02 | Civco Medical Instruments Co. Inc. | There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified |
| 2026-03-02 | Civco Medical Instruments Co. Inc. | There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified |
| 2022-01-24 | Volcano Corp | Multi-Modality Touch Screen Modules (MM-TSM), which are bedside/secondary control units, used as part of Mobile IVUS systems, are missing the following labeling information: Unique |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.