Z-2586-2021 Class II Terminated

Recalled by Deerfield Imaging, Inc. — Minnetonka, MN

Recall Details

Product Type
Devices
Report Date
October 6, 2021
Initiation Date
August 25, 2021
Termination Date
April 30, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
3 units

Product Description

Operating room table - Product Usage: intended for use during diagnostic examinations, radiologic procedures or surgical procedures to support and position a patient.

Reason for Recall

ORT200/300 rotational lock may fail to function such that it cannot change states between locked and unlocked, due to a mechanical hardware issue.

Distribution Pattern

Worldwide distribution - US Nationwide distribution FL, NH, TX, OH, CA, OR, UT, TN, NC and the countries of Canada, Australia, Sweden, Japan.

Code Information

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