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DOMICO MED-DEVICE, LLC · Model 15 · UDI-DI 00810050242165
10
510(k) clearances
418
Adverse events (7 deaths)
27
Recalls
29
Facilities
Description
KIT, SMALL, "I". Includes: 127 - HOLDER, CHILD AP-PA HEAD (00810050240307), 132 – SUPPORT, HEAD/NECK, 6.5” x 10” x 12” (00810050240208), 133 – REST, CERVICAL HEAD (00810050240055), 136 – WEDGE, 2.25” x 8” x 10” (00810050240338), 138 – WEDGE, 3.75” x 8” x 10” (00810050240161), 139 – WEDGE, 7” x 7” x 10” (00810050240345), 169 – RECTANGLE, 3” x 7.5” x 10” (00810050240413)
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-08-06 | IMRIS Imaging Inc | The linear actuator and rotational lock mechanism components may experience a mechanical failure that prevents the system from transitioning between locked and unlocked state. This |
| 2025-02-25 | Baxter Healthcare Corporation | There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled. |
| 2025-02-25 | Baxter Healthcare Corporation | There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled. |
| 2025-02-25 | Baxter Healthcare Corporation | There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled. |
| 2025-02-25 | Baxter Healthcare Corporation | There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled. |
| 2025-02-25 | Baxter Healthcare Corporation | There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled. |
| 2021-08-25 | Deerfield Imaging, Inc. | ORT200/300 rotational lock may fail to function such that it cannot change states between locked and unlocked, due to a mechanical hardware issue. |
| 2021-08-25 | Deerfield Imaging, Inc. | ORT200/300 rotational lock may fail to function such that it cannot change states between locked and unlocked, due to a mechanical hardware issue. |
| 2021-08-25 | Deerfield Imaging, Inc. | ORT200/300 rotational lock may fail to function such that it cannot change states between locked and unlocked, due to a mechanical hardware issue. |
| 2019-11-04 | Villa Sistemi Medicali S.P.A. | An amendment to the IFU and Service Manual is being issued to prescribe the replacement of the angulation chain after 8 years of service of the of the unit. After testing, it was |
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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.