Agency classClass IIOur severity:High FDA (Devices)·Z-0648-2019·Announced 2018-12-26

Deerfield Imaging Recalls IMRIS ORT 300 Operating Room Tables

Deerfield Imaging is recalling 14 IMRIS ORT 300 operating room tables because they may drift in the roll position while in use.

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 affect patient safety during procedures, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Deerfield Imaging, Inc. is recalling 14 units of the IMRIS ORT 300 Removable Operating Room Table. The affected units include part numbers 114093-000 and 114093-006. These tables are intended for use during diagnostic examinations, radiologic procedures, or surgical procedures to support and position a patient.

The recall is being conducted because the table may drift in the roll position while in use. This defect could potentially compromise patient positioning during procedures.

The affected units were distributed worldwide, including the United States, China, Qatar, Canada, Australia, Japan, France, Germany, Sweden, and Italy. Healthcare facilities should contact Deerfield Imaging for instructions on how to address the issue.

The recalled product

Product: IMRIS ORT 300, Removable Operating Room Table, Part Numbers: (a) 114093-000, (b) 114093-006 - Product Usage: The ORT200 and ORT300 are intended for use during diagnostic examinations, radiologic procedures, or surgical procedures to support and position a patient. The tables…
Manufacturer: Deerfield Imaging, Inc.
Category: Medical Device — Operating Room Table
Hazard: mechanical-defect
patient-positioning
Affected units: 14

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
10002385
10005613 (b) 114093-006
Serial Numbers: 10007411
10002996
10004515

Distribution

Distributed nationwide across the United States.

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 Due to Hardware Defect
FDA (Devices) · 2021-10-06
High
Operating Room Table Rotational Lock May Fail to Function
FDA (Devices) · 2021-10-06
High
Operating room table rotational lock may fail to maintain position
FDA (Devices) · 2021-10-06
Moderate
Deerfield iMRX MRI and Angiography System Recalled for Hardware Error
FDA (Devices) · 2020-01-08

Same hazard · mechanical defect