Agency classClass IIOur severity:High FDA (Devices)·Z-1265-2018·Announced 2018-04-04

Deerfield Imaging Recalls IMRIS T2X Operating Room Tables

Deerfield Imaging is recalling 14 IMRIS T2X 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 specific injuries or illnesses have been reported in the source text.

Plain-English summary

Deerfield Imaging, Inc. is recalling 14 units of the IMRIS T2X Table. The affected units are identified by specific part numbers and serial numbers, including 108000-000, 108000-600, 109682-000, and 109682-600.

The recall was initiated because the operating room table may drift while in use. This defect could potentially result in unintended movement of the table during procedures. The agency has classified this as a Class II recall.

The affected units were distributed in the United States, Canada, China, Australia, Sweden, and Germany. Healthcare facilities should check their inventory for the specific serial numbers listed in the recall notice and contact Deerfield Imaging for further instructions.

The recalled product

Product: IMRIS T2X Table, Part Numbers: (a) 108000-000 (b) 108000-600 (c) 109682-000 (d) 109682-600
Manufacturer: Deerfield Imaging, Inc.
Category: Medical Device — Operating Room Table
Hazard: unintended-movement
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) 108000-000
Serial Numbers: 10000239
10000983
10000233 (b) 108000-600
Serial Numbers: 10001306 (c) 109682-000
Serial Numbers: 10002375
10001118
10001340 (d) 109682-600
Serial Numbers: 10001119
10003623
05-002
10003634
10001188
10003638
10001192

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