Agency classClass IIOur severity:High FDA (Devices)·Z-1264-2018·Announced 2018-04-04

Deerfield Imaging Recalls IMRIS ORT200 Operating Room Tables for Drift Risk

Deerfield Imaging is recalling 17 IMRIS ORT200 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 is classified as FDA Class II and involves a risk-of-harm product (unintended movement of an operating table) where no injuries have been reported, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Deerfield Imaging, Inc. is recalling 17 units of the IMRIS ORT200 Removable Operating Room Table. The affected units are identified by specific part numbers (113821-000, 113821-600, 114148-000, 114148-600) and serial numbers listed in the agency's structured data. The recall covers units distributed in the US, Canada, China, Australia, Sweden, and Germany.

The recall is being conducted because the operating room table may drift while in use. This defect could potentially result in unintended movement of the table. The U.S. Food and Drug Administration has classified this as a Class II recall, indicating a reasonable probability that use of the product could cause temporary or medically reversible adverse health consequences.

Healthcare facilities and users should contact Deerfield Imaging, Inc. for instructions on how to address the defect. The source text does not report any specific injuries or illnesses associated with this recall.

The recalled product

Product: IMRIS ORT200, Removable Operating Room Table, Part Numbers: (a) 113821-000 (b) 113821-600 (c) 114148-000 (d) 114148-600
Manufacturer: Deerfield Imaging, Inc.
Category: Medical Device — Operating Room Table
Hazard: unintended-movement
Affected units: 17

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 (17)

(a) 113821-000
Serial Numbers: 10006997
10002220 (b) 113821-600
Serial Numbers: 10002692
10006152
10007192
10006991
10003754
10006997
10004513 (c) 114148-000
Serial Numbers: 10004463
10005189
10005190
10006891
10004997
10004327 (d) 114148-600
Serial Numbers: 10005201

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