Agency classClass IIOur severity:High FDA (Devices)·Z-0976-2018·Announced 2018-03-21

Deerfield IMRIS T2X Table Recall Due to Rotational Locking Defect

Deerfield Imaging is recalling 16 IMRIS T2X tables because the rotational locking mechanisms can disengage, potentially causing unintended table 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 involves a risk-of-harm product (medical device) where unintended movement could cause injury, but no specific injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria.

Plain-English summary

Deerfield Imaging, Inc. is recalling 16 IMRIS T2X Tables (Part Number 109682-600) due to a defect in the rotational locking mechanisms. The affected tables were distributed in the United States, Canada, Australia, China, and Qatar.

The recall was initiated because the rotational locking mechanisms on the ORT 100/T2X tables can become disengaged or unlocked while in use. This malfunction could potentially result in unintended movement of the table.

Specific serial numbers for the affected units are listed in the official recall documentation. Users of these devices should contact Deerfield Imaging, Inc. for further instructions regarding the recall and corrective actions.

The recalled product

Product: IMRIS T2X Table, Part Number 109682-600
Manufacturer: Deerfield Imaging, Inc.
Category: Medical Device — Imaging Table
Hazard: unintended-movement
mechanical-failure
Affected units: 16

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)

Serial Numbers: 10000239
10001306
10000983
10000982
10000233
10001119
10001192
10002375
10003623
05 002
10003634
10001118
10001188
10001340
10003638

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 2 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 2 products in this recall →

Same manufacturer · Deerfield Imaging, Inc.

See all →

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

Same hazard · unintended movement