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DOMICO MED-DEVICE, LLC · Model 9124 · UDI-DI 00810050244596
Description
ACCESSORY KIT, CARTESION PRIME. Includes: 9006 - STRAP, CHIN (00810050242103), 9007 - STRAP, FOREHEAD W/ADULT PAD (00810050242134), 9008 - KIT, ADULT HEAD REST (00810050243209), 9009 - WEDGE, TILT (00810050242431), 9017 - WEDGE, KNEE, 10.7” x 21.88” x 18.33” (00810050242424), 9020F - PAD, PEDIATRIC POSITIONING (00810050241441), 9025 - HOLDER, CORONAL HEAD (00810050241229), 9061 – STRAP, WIDE SECURITY, 14.17” x 21.12” (20810050242909), 9062 - STRAP, NARROW SECURITY FOR THE SHIELD (20810050242886), 9080 - SLIDE RAIL, DETACHABLE, AQULION ONE (10810050242841), 9092 - PAD, AQUILION ONE ADULT HOLDER (00810050241380), 9093 - PAD, AQUILION ONE CHILD HOLDER (00810050241397), 9094 - PAD, AQUILION ONE PEDIATRIC HOLDER (00810050242448), 9095 - PAD, AQUILION ONE WEDGE (00810050241403), 9096 - WEDGE, TAPER, 1.5” x 3.5” x 3” (10810050243008), 9097 - STRAP, VELTEX, 2” x 22” (10810050242896), 9112 - COVER, PROTECTIVE, FOOT EXTENSION PAD (10810050242674), 9113 - STRAP, WIDE BARIATRIC EXTENDER 30" (00810050242172), 9114 - STRAP, NARROW BARIATRIC EXTENDER 30" (00810050242158), 9121 – TABLE PAD COVER (00861001002659), 9122 – TABLE PAD, CARTESION PRIME (00810050244572), 9123 – FOOT PAD, CARTESION PRIME (00810050244589)
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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