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SA300 Series
DENTIS CO. ,LTD · Model SA300-300000 · UDI-DI 08800053092296
FQO
Prescription
10
510(k) clearances
2,406
Adverse events (16 deaths)
73
Recalls
76
Facilities
Description
Suspension Arm(SA300 Series) is intended to be used to provide easy angle adjustment and movement of the surgical luminaire.
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 |
| 2025-07-14 | MAQUET GMBH | Under certain conditions, such as the simultaneous use of the operating table with other medical devices, including high-frequency (HF) surgical equipment, interference may occur t |
| 2025-03-27 | IHB OPERATIONS B.V. | The mounting hardware that is supplied with the 4FXS-60 monitor bracket does not provide adequate thread engagement to support the weight of the frame and monitor. This could lead |
| 2024-10-03 | Getinge Usa Sales Inc | Error code "50037" occurs on the IR-Hand Control when a MEERA-table is controlled, and the table stops the movement. This error may occur sporadically when the MEERA-table is contr |
| 2024-10-03 | Getinge Usa Sales Inc | Error code "50037" occurs on the IR-Hand Control when a MEERA-table is controlled, and the table stops the movement. This error may occur sporadically when the MEERA-table is contr |
| 2024-10-03 | Getinge Usa Sales Inc | Error code "50037" occurs on the IR-Hand Control when a MEERA-table is controlled, and the table stops the movement. This error may occur sporadically when the MEERA-table is contr |
| 2024-10-03 | Getinge Usa Sales Inc | Error code "50037" occurs on the IR-Hand Control when a MEERA-table is controlled, and the table stops the movement. This error may occur sporadically when the MEERA-table is contr |
| 2024-10-03 | Getinge Usa Sales Inc | Error code "50037" occurs on the IR-Hand Control when a MEERA-table is controlled, and the table stops the movement. This error may occur sporadically when the MEERA-table is contr |
| 2024-10-03 | Getinge Usa Sales Inc | Error code "50037" occurs on the IR-Hand Control when a MEERA-table is controlled, and the table stops the movement. This error may occur sporadically when the MEERA-table is contr |
| 2024-10-03 | Getinge Usa Sales Inc | Error code "50037" occurs on the IR-Hand Control when a MEERA-table is controlled, and the table stops the movement. This error may occur sporadically when the MEERA-table is contr |
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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.