U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
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.
조치
All consignees were notified by telephone and a recall letter was mailed to each facility as a follow up. Customers were asked to remove tables from operation until they were inspected by OSI service personnel.
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 lateral position depending on the specific table top utilized.