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RiEye Mk2S
Rini Ergoteknik AB · Model Rn · UDI-DI 07350136560002
10
510(k) clearances
1,601
Adverse events (1 deaths)
27
Recalls
115
Facilities
Description
Operating table mainly for eye surgery, IVT eye injections, plastic surgery, dental and Jaw and similar micro surgical procedures.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-04-21 | Baxter Healthcare Corporation | The Adapter for Head Positioning accessory may become loose during patient positioning and unintentionally move when used in conjunction with the side rails of the Upper Back Secti |
| 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. |
| 2024-09-19 | Baxter Healthcare Corporation | The firm received customer reports stating that the batteries and their connectors experienced electrical short-circuits and/or emitted smoke. |
| 2024-06-28 | Baxter Healthcare Corporation | Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction for the PST 500 U Precision Surgical Table due to a potential issue with loose spring pins in the spind |
| 2023-08-01 | Skytron, LLC | When the control of the operating table was used in Bluetooth mode, the operating table continued moving even after releasing the button on the control. Originally, the root cause |
| 2023-08-01 | Skytron, LLC | When the control of the operating table was used in Bluetooth mode, the operating table continued moving even after releasing the button on the control. Originally, the root cause |
| 2023-05-18 | Baxter Healthcare Corporation | Potential for the device to crack where the Chest Base Prone support attaches to the carbon fiber operating room (OR) table rail. |
| 2022-09-20 | Baxter Healthcare Corporation | the adhesive, applied to screws and bolts as an additional holding force, may not cure correctly, and as a result, could result in a loss of holding and reduced mechanical integrit |
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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.