FDA recall Z-1263-2018
Deerfield Imaging, Inc. · Class II · device
Product
IMRIS ORT100 Table, Part Numbers: (a) 110470-000 (b) 110470-600
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-1263-2018