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MyLabSeven LCD 19"
ESAOTE SPA · Model 101640001 · UDI-DI 08056304450340
10
510(k) clearances
6,516
Adverse events (17 deaths)
82
Recalls
350
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 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 |
| 2021-11-04 | GE Healthcare, LLC | The firm identified that the Vscan Extend device will not power on because of depleted battery, due to the device not being turned off prior to battery removal or when being connec |
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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.