Z-0792-2016Class II

Mizuho OSI Trios, Table Base; Voltage: 100-240V ~ 50/60 Hz Amps: 5,0-5.0A; Model 7803 and 7803AP Orthopaedic...

Name: Z-0792-2016 Mizuho OSI Trios, Table Base; Voltage: 100-240V ~ 50/60 Hz Amps: 5,0-5.0A; Model 7803 and 7803AP Orthopaedic...
Creator: Mizuho OSI
Published: 2015-12-14
License: https://open.fda.gov/license/

Mizuho Orthopedic Systems Inc / initiated 2015-12-14 / Terminated / root cause: manufacturing process

FDA source

Mizuho OSI began a recall of 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... on 2015-12-14. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0792-2016
Classification: Class II
Status: Terminated
Initiated: 2015-12-14
Posted: 2016-02-09
Terminated: 2016-02-10
Recalling firm: Mizuho Orthopedic Systems Inc
Product: 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.
Product code: GDC Table, Operating-Room, Electrical
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: 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.
Quantity in commerce: 33
Distribution: US, South Africa, Japan and United Arab Emirates.
Product codes and lots: Model numbers 7803, 7803AP. Serial numbers 228-261.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0792-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0792-2016	Class II	Terminated	Voluntary: Firm initiated	2016-02-17	2016-02-09

Product code GDC

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)