RecallRadar

FDA Device recall Z-1218-2018

IMRIS ORT300 Removable Operating Room Table, 50-60 Hz Version is intended for use during diagnostic examinations or surgical procedures to…

On 2018-04-04 the FDA classified a Class II recall of IMRIS ORT300 Removable Operating Room Table, 50-60 Hz Version is intended for use during diagnostic examinations or surgical procedures to… by Deerfield Imaging, citing the rotational locking mechanisms on the ORT 200/300 tables fail to operate such that it cannot change states between locked and unlocked.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1218-2018
ClassificationClass II
Statusterminated
Initiated2018-02-23
Published2018-04-04
Last updated2026-09-13 11:54 UTC
CompanyDeerfield Imaging
Distributionn/a

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

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

Identifiers

code_infoSerial numbers: 10005695, 10002998, 10005456, 10007411, 10007377, 10002997, 10002996, 10005612, 10004372, 10002841, 10004515, 10005613, 10002255

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1218-2018%22

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