Agency classClass IIOur severity:High FDA (Devices)·Z-2584-2021·Announced 2021-10-06

Operating Room Table Rotational Lock May Fail Due to Hardware Defect

The rotational locking mechanism on certain ORT200/300 operating room tables may fail to lock or unlock due to a mechanical hardware defect. Affected tables have been distributed worldwide.

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 FDA Class II medical device recall involves a mechanical locking failure with no reported illnesses or injuries. The defect creates a risk-of-harm scenario for patient positioning and safety. Per the rubric, risk-of-harm products without reported injury score at 3 (High).

Plain-English summary

Deerfield Imaging, Inc. is recalling 13 ORT200/300 operating room tables because the rotational lock mechanism may fail to function properly. The rotational lock may not be able to change between locked and unlocked states due to a mechanical hardware defect.

The affected operating room tables are used during diagnostic examinations, radiologic procedures, and surgical operations to support and position patients. The inability to properly lock or unlock the table could create a safety concern during these procedures.

The 13 affected units have been distributed worldwide to healthcare facilities in Florida, New Hampshire, Texas, Ohio, California, Oregon, Utah, Tennessee, North Carolina, as well as Canada, Australia, Sweden, and Japan. Specific model and serial numbers are provided in the official recall notice.

Healthcare providers with affected equipment should contact Deerfield Imaging, Inc. to determine if their units are included in this recall and verify proper functioning of the rotational lock mechanism before continued use.

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 Equipment
Hazard: locking-mechanism-failure
patient-fall-risk
Affected units: 13

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 (12)

Model Number: 113821-600 (Serial Numbers: 10002692
10006152
10006991
10004513
10006997
and 10003754)
Model Number: 114148-000 (Serial Numbers: 10004463
10006891
10005189
10005190
10004327
and 10004997)

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 to Function
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 · locking mechanism failure