Deerfield Imaging, Inc. recalls IMRIS ORT300 Removable Operating Room Table, 50-60 Hz Version is intended for use during diagnostic examinations or sur…
- Recall date
- February 23, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1218-2018
- FDA classification
- Class II
- Brand / firm
- Deerfield Imaging, Inc.
- Sold / distributed
- US, Canada, China, Sweden, Germany, Japan, Qatar, France, Audtralia
Why it was recalled
The rotational locking mechanisms on the ORT 200/300 tables fail to operate such that it cannot change states between locked and unlocked.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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.
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