FDAClass IIApril 4, 2018

IMRIS ORT300 Removable Operating Room Table recall

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

Why was IMRIS ORT300 Removable Operating Room Table recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
IMRIS ORT300 Removable Operating Room Table, 50-60 Hz Version is intended for use during diagnostic examinations or surgical procedures to support and…
Recalling firm
Deerfield Imaging, Inc.
Quantity
13 units
Distribution
US, Canada, China, Sweden, Germany, Japan, Qatar, France, Audtralia
Recall date
April 4, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
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