Agency classClass IIOur severity:High FDA (Devices)·Z-0645-2019·Announced 2018-12-26

Deerfield Imaging Recalls IMRIS T2X Tables Due to Roll Position Drift

Deerfield Imaging is recalling 15 IMRIS T2X 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 the hazard involves a risk of harm to patients during procedures, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Deerfield Imaging, Inc. is recalling 15 units of the IMRIS T2X table. The affected part numbers are 108000-000, 108000-600, 109682-000, 109682-600, and 110470-600. These tables are intended for use during diagnostic examinations, radiologic procedures, or surgical procedures to support and position a patient.

The recall is being issued because the table may drift in the roll position while in use. This defect could affect the stability of the patient during procedures.

The affected units were distributed worldwide, including in the United States, China, Qatar, Canada, Australia, Japan, France, Germany, Sweden, and Italy. Specific serial numbers for the affected units are listed in the agency's recall documentation.

The recalled product

Product: IMRIS T2X table, Part Numbers: (a)108000-000, (b)108000-600, (c)109682-000, (d) 109682-600, (e) 110470-600 - Product Usage: The ORT200 and ORT300 are intended for use during diagnostic examinations, radiologic procedures, or surgical procedures to support and position a…
Manufacturer: Deerfield Imaging, Inc.
Category: Medical Device — Imaging Table
Hazard: mechanical-defect
patient-positioning
Affected units: 15

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 (16)

(a)108000-000
Serial Numbers: 10000983
10000652 (b)108000-600
Serial Numbers: 06-0025
10001306 (c)109682-000
Serial Numbers: 10002375
10001118
10001340 (d)109682-600
Serial Numbers: 10001119
10001188
10003634
05-002
10003638
10003623
10001305 (e)110470-600
Serial Numbers: 10006887

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.

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Same hazard · mechanical defect