Agency classClass IIOur severity:High FDA (Devices)·Z-0975-2018·Announced 2018-03-21

Deerfield Imaging Recalls IMRIS ORT100 Tables Due to Locking Mechanism Defect

Deerfield Imaging is recalling 15 IMRIS ORT100 tables because the rotational locking mechanisms can disengage, 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 involves a structural defect in a medical device that could cause unintended movement, representing a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Deerfield Imaging, Inc. is recalling 15 IMRIS ORT100 Tables, Part Number 110470-000. The recall affects specific serial numbers listed in the agency documentation. These devices were distributed in the United States, Canada, Australia, China, and Qatar.

The recall is due to a defect in the rotational locking mechanisms on the ORT 100/T2X tables. These mechanisms can become disengaged or unlocked while the table is in use. This failure could potentially result in unintended movement of the table.

Healthcare facilities and users should identify if they possess any of the affected serial numbers. They should contact Deerfield Imaging, Inc. for instructions on how to address the defect.

The recalled product

Product: IMRIS ORT100 Table, Part Number 110470-000
Manufacturer: Deerfield Imaging, Inc.
Category: Medical Device — Surgical Table
Hazard: unintended-movement
mechanical-failure
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 (15)

Serial Numbers: 10002341
10003629
10003801
10002654
10002795
10002796
10002847
10003830
10003243
10002848
10003241
10005651
10007348
10007424
10006886

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 →

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 · unintended movement