Agency classClass IIOur severity:High FDA (Devices)·Z-1266-2018·Announced 2018-04-04

Deerfield Imaging Recalls IMRIS ORT300 Operating Room Tables Due to Drift Risk

Deerfield Imaging is recalling 13 IMRIS ORT300 operating room tables because they may drift during use, potentially causing unintended movement.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a mechanical defect that could cause unintended movement during use, representing a risk of harm where injury has not yet been reported.

Plain-English summary

Deerfield Imaging, Inc. is recalling 13 units of the IMRIS ORT300 Removable Operating Room Table. The affected units include part numbers 114093-000 and 114093-600. The recall is due to a defect where the operating room table may drift while in use.

This drift could potentially result in unintended movement of the table. The affected units were distributed in the United States, Canada, China, Australia, Sweden, and Germany.

Healthcare facilities should contact Deerfield Imaging, Inc. for instructions on how to address the defect. Specific serial numbers for the affected units are listed in the official recall documentation.

The recalled product

Product: IMRIS ORT300, Removable Operating Room Table, Part Numbers: (a) 114093-000 (b) 114093-600
Manufacturer: Deerfield Imaging, Inc.
Category: Medical Device — Operating Room Table
Hazard: unintended-movement
mechanical-defect
Affected units: 13

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (14)

(a) 114093-000
Serial Numbers: 10005695
10002998
10005456
10007377
10002997
10005612
10004372
10002841
10002255
10005613 (b) 114093-600
Serial Numbers: 10007411
10002996
10004515

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 4 recalled by Deerfield Imaging, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

Same manufacturer · Deerfield Imaging, Inc.

See all →

High
Surgical Head Fixation Device Mount Clamp Assembly Deflection Recall
FDA (Devices) · 2022-04-20
High
Operating room table rotational lock may fail to maintain position
FDA (Devices) · 2021-10-06
High
Operating Room Table Rotational Lock May Fail Due to Hardware Defect
FDA (Devices) · 2021-10-06
High
Operating Room Table Rotational Lock May Fail to Function
FDA (Devices) · 2021-10-06
Moderate
Deerfield iMRX MRI and Angiography System Recalled for Hardware Error
FDA (Devices) · 2020-01-08

Same hazard · unintended movement