Agency classClass IIOur severity:High FDA (Devices)·Z-0647-2019·Announced 2018-12-26

Deerfield Imaging Recalls IMRIS ORT 200 Tables Due to Roll Drift

Deerfield Imaging is recalling 14 IMRIS ORT 200 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 is classified as FDA Class II and involves a risk-of-harm product (operating room table) where injury has not yet been reported, fitting the criteria for a High severity score.

Plain-English summary

Deerfield Imaging, Inc. is recalling 14 units of the IMRIS ORT 200 Removable Operating Room Table. The affected units are identified by specific part numbers and serial numbers listed in the recall documentation. The tables are intended for use during diagnostic examinations, radiologic procedures, or surgical procedures to support and position a patient.

The recall was initiated because the table may drift in the roll position while in use. This defect could potentially affect patient positioning during procedures. The agency has classified this recall as Class II.

The affected units were distributed worldwide, including in the United States, China, Qatar, Canada, Australia, Japan, France, Germany, Sweden, and Italy. Healthcare facilities that have these specific units should stop using them and contact Deerfield Imaging for instructions on corrective action.

The recalled product

Product: IMRIS ORT 200, Removable Operating Room Table, Part Numbers: (a) 113821-000, (b) 113821-600, (c) 114148-000, (d) 114148-600 - Product Usage: The ORT200 and ORT300 are intended for use during diagnostic examinations, radiologic procedures, or surgical procedures to support and…
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 (15)

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

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 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 · mechanical defect