FDA recall Z-1264-2018

Deerfield Imaging, Inc. · Class II · device

Product

IMRIS ORT200, Removable Operating Room Table, Part Numbers: (a) 113821-000 (b) 113821-600 (c) 114148-000 (d) 114148-600

Reason for recall

The Operating Room Table may drift while in use, which could potentially result in unintended movement of the table.

Distribution

US, Canada, China, Australia, Sweden, Germany

Key facts

Status
Terminated
Initiation date
2018-02-23
Report date
2018-04-04
Termination date
2019-09-12
Voluntary/Mandated
Voluntary: Firm initiated
Location
Minnetonka, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1264-2018