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Leg Traction Device
MIZUHO CORPORATION · Model 08-115-12 · UDI-DI 04946329068702
GDC
Prescription
10
510(k) clearances
1,601
Adverse events (1 deaths)
27
Recalls
115
Facilities
Description
Lower Thigh Support for Traction in Lateral Posture
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.