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DOMICO MED-DEVICE, LLC · Model 99 · UDI-DI 00810050245074
10
510(k) clearances
418
Adverse events (7 deaths)
27
Recalls
29
Facilities
Description
KIT, CT POSITIONING. Includes 105 - WEDGE, 3.75” x 9” x 8”, (10810050242995), 106 - WEDGE, 6.63” x 6.63” x 12” (00810050242318), 113 - WEDGE, 2.25” x 9.5” x 7.25”, (10810050242926), 118 - WEDGE, 7” x 7” x 7” (00810050242387), 120 - WEDGE, 2.50” x 8” x 7” (00810050242301), 123 - WEDGE, 6.63” x 9” x 12” (00810050242325), 130 – WEDGE, 10" x 10" x 10" (00810050240826), 136 – WEDGE, 2.25” x 8” x 10” (00810050240338), 138 – WEDGE, 3.75” x 8” x 10” (00810050240161), 140 – WEDGE, 6" x 10" x 10" (00810050240369)
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.