Agency classClass IIOur severity:High FDA (Devices)·Z-1263-2018·Announced 2018-04-04

Deerfield Imaging Recalls IMRIS ORT100 Operating Room Tables

Deerfield Imaging is recalling 26 IMRIS ORT100 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 involves a medical device with a mechanical defect that could cause unintended movement during use, representing a risk of harm where injury has not yet been reported.

Plain-English summary

Deerfield Imaging, Inc. is recalling 26 units of the IMRIS ORT100 Operating Room Table. The affected units include part numbers 110470-000 and 110470-600. The recall covers specific serial numbers listed in the agency's structured data.

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 affected products were distributed in the United States, Canada, China, Australia, Sweden, and Germany. Users of these devices should contact Deerfield Imaging, Inc. for further instructions on how to address the issue.

The recalled product

Product: IMRIS ORT100 Table, Part Numbers: (a) 110470-000 (b) 110470-600
Manufacturer: Deerfield Imaging, Inc.
Category: Medical Device — Operating Room Table
Hazard: unintended-movement
Affected units: 26

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 (20)

(a) 110470-000
Serial Numbers: 10002845
10002341
10003629
10003801
10002654
10002795
10002796
10002847
10003830
10003243
10003241
10002607
10002848
10005651
10007348
10007424
10004250
10004439
10004576

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