Operating room table - Product Usage: intended for use during diagnostic examinations, radiologic procedures or surgical procedures to support and position a patient.
Recall
- Recall Number
- Z-2585-2021
- Event Number
- 88661
- Firm
- Deerfield Imaging, Inc.
- FEI Number
- 3010326005
- Product Code
- KXJ
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- August 25, 2021
- Terminated
- April 30, 2024
- Address
- 5101 Shady Oak Rd S, Minnetonka, MN, 55343-4100
Description
Operating room table - Product Usage: intended for use during diagnostic examinations, radiologic procedures or surgical procedures to support and position a patient.
ORT200/300 rotational lock may fail to function such that it cannot change states between locked and unlocked, due to a mechanical hardware issue.
A Recall notification letter titled, "URGENT FIELD CORRECTION NOTICE" was sent to consignees on 08/25/2021 via Fed-Ex. E-mail communications were also sent to the customers on 8/26/2021. The letter instructs the consignee to fill out the second page of the notice and return it to the firm. The letter states that the IMRIS Customer Service will contact the consignee to schedule implementation of this corrective action with the facility. The letter mentions that, "IMRIS recommends these preventive actions: Per the OR Table Operator Manuals, the table should be tested daily in all standard positions and inspected for anomalies including the fit of the covers, tabletops, headrest, pendant connection and rotation. During usage, verify the table position is locked by manually pushing the table to ensure it does not exhibit rotational movement. If the rotational lock is observed to not function properly, please contact IMRIS Customer Service immediately."
Worldwide distribution - US Nationwide distribution FL, NH, TX, OH, CA, OR, UT, TN, NC and the countries of Canada, Australia, Sweden, Japan.
10 units