FDADecember 14, 2015device
Mizuho OSI Trios, Table Base; Voltage: 100-240V ~ 50/60 Hz Amps: 5,0-5.0A; Model 7803 and 7803AP Orthopaedic: Operating room tablebase - an electronically powered mobile operating table is created, designed for temporary (<24 hours) support and positioning of a patient in a prone, supine, or late...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Table Bases may have been assembled incorrectly, missing a retaining ring from the head end assembly. Over time, the parts could go out of alignment, making clutch engagement or disengagement difficult. If the clutch cannot disengage, the user would be unable to rotate the patient from supine to prone.
What to do
FDA enforcement status: Terminated
Brands named
mizuho osimizuho
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAHANA/PROFx CLASSIC FEMORAL HOOK RIGHT REF 6850-1442021-07-29
- FDAMizuho CE IPX4, mode MOT-5602BW, 100-240, 50-60Hz, 400VA, REF 18-140-20 containing hand control Unit - Product Usage: intended to support a patient during surgical operations.2021-02-08
- USDA FSISOSI Industries, LLC Recalls Ready-To-Eat Beef Patty Products Due to Possible Foreign Matter Contamination2019-10-28
- FDALevo Arm Label: LEVO ARM REF 7887-050 MIZUHO OSI Refurbished Levo Arm Label: LEVO ARM REF 7887-050R MIZUHO OSI - Product Usage: used with Mizuho OSI spinal surgery tables to provide patient head support and positioning during spinal surgery.2019-10-14
- FDAMicrosurgical Operating Room Tables;7300BX (18-351-70).2019-09-11
- FDAMicrosurgical Operating Room Tables;7300B (18-350-70);2019-09-11
- FDA216 Wilson Frame Pads, Model # 5319-37; Used with Radiolucent Wilson Frames, model numbers 5319G and 5321G. General and Plastic Surgery: These pads are used as a component of the Wilson Frames, which support the torso of a prone patient during spine surgery. The pads are supplied with the frames ...2017-03-28
- USDA FSISOSI Industries, LLC Recalls Chicken Products Due To Possible Foreign Matter Contamination2016-11-06
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