Agency classClass IIOur severity:High FDA (Devices)·Z-2586-2021·Announced 2021-10-06

Operating room table rotational lock may fail to maintain position

The rotational lock on certain operating room tables may fail to secure the table position. This could cause the table to move unexpectedly during diagnostic or surgical 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 a Class II FDA recall of a surgical positioning device where the hazard—rotational lock failure—creates a risk to patient positioning during procedures. No injuries or illnesses have been reported in the source text, so the score is High (3) per the rubric for risk-of-harm products without reported injury.

Plain-English summary

Deerfield Imaging, Inc. is recalling operating room tables due to a potential failure in the rotational lock mechanism. The lock may fail to change states between locked and unlocked positions due to a mechanical hardware issue.

The affected operating room tables are used in diagnostic examinations, radiologic procedures, and surgical operations to support and position patients. If the rotational lock fails to engage properly, the table position may change unexpectedly during a procedure, potentially placing patients at risk.

Three units are affected with the following serial numbers: 10007411, 10002996, and 10004515 (Model 114093-600, UDI 00857534006462). These units have been distributed worldwide to facilities in the United States (Florida, New Hampshire, Texas, Ohio, California, Oregon, Utah, Tennessee, North Carolina) and internationally to Canada, Australia, Sweden, and Japan.

If you have one of the affected units, contact Deerfield Imaging, Inc. immediately to discuss the issue and any corrective actions. Healthcare facilities should inspect their equipment and document any history of lock malfunction or positioning problems.

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 — Operating Room Equipment
Hazard: mechanical-failure
positioning-hazard
Affected units: 3

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 (5)

UDI: 00857534006462
Model Number: 114093-600
Serial Number: 10007411
10002996
10004515.

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 Function
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