Agency classClass IIOur severity:High FDA (Devices)·Z-2585-2021·Announced 2021-10-06

Operating Room Table Rotational Lock May Fail to Function

Deerfield Imaging operating room tables (ORT200/300) may have a mechanical defect in the rotational lock, preventing it from changing between locked and unlocked states. This could affect patient positioning during procedures.

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: This is an FDA Class II recall of a mechanical defect in operating room table equipment that affects a critical patient-positioning function. While no injuries have been reported, the failed rotational lock presents a risk of harm during surgical procedures, meeting the rubric criterion for High severity: risk-of-harm products where injury has not yet been reported.

Plain-English summary

Deerfield Imaging, Inc. manufactures operating room tables (model ORT200/300) intended for use during diagnostic examinations, radiologic procedures, and surgical procedures. These tables are designed to support and position patients during medical procedures.

The recalled tables have a mechanical hardware defect affecting the rotational lock. The lock may fail to function properly and cannot reliably change between locked and unlocked states, potentially affecting the table's ability to maintain proper patient positioning during procedures.

A total of 10 units are affected by this defect. These units have been distributed across the United States (including Florida, New Hampshire, Texas, Ohio, California, Oregon, Utah, Tennessee, and North Carolina) and internationally to Canada, Australia, Sweden, and Japan.

This recall was issued due to the mechanical defect in the rotational lock mechanism that could impact patient safety during surgical and diagnostic procedures.

The recalled product

Product: Operating room table - Product Usage: intended for use during diagnostic examinations, radiologic procedures or surgical procedures to support and position a patient.
Manufacturer: Deerfield Imaging, Inc.
Category: Medical Device — Surgical Support Equipment
Hazard: mechanical-failure
positioning-defect
Affected units: 10

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 (11)

UDI: 00857534006356 Model Number: 114093-000
Serial Numbers: 10005695
10002998
10005456
10007377
10002997
10006737
10004372
10002841
10005613
and 10002255.

Distribution

Distributed nationwide across the United States.

The notice also names 9 states specifically:

Part of a larger recall action

This product is one of 3 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 3 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
Moderate
Deerfield iMRX MRI and Angiography System Recalled for Hardware Error
FDA (Devices) · 2020-01-08
Severe
Deerfield Imaging Recalls IMRIS Head Fixation Devices Due to Knob Failure
FDA (Devices) · 2019-10-30

Same hazard · mechanical failure