FDA recall Z-1218-2018

Product

IMRIS ORT300 Removable Operating Room Table, 50-60 Hz Version is intended for use during diagnostic examinations or surgical procedures to support and position a patient.

Reason for recall

The rotational locking mechanisms on the ORT 200/300 tables fail to operate such that it cannot change states between locked and unlocked.

Distribution

US, Canada, China, Sweden, Germany, Japan, Qatar, France, Audtralia

Key facts

Status

Terminated

Initiation date

2018-02-23

Report date

2018-04-04

Termination date

2019-08-27

Voluntary/Mandated

Voluntary: Firm initiated

Location

Minnetonka, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1218-2018