Z-2585-2021 Class II Terminated
FDA device recall Z-2585-2021 was initiated by Deerfield Imaging, Inc. on August 25, 2021 and is designated Class II. 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. The recall status is terminated (terminated April 30, 2024). Affected quantity: 10 units.
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
- 10 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: 00857534006356 Model Number: 114093-000; Serial Numbers: 10005695, 10002998, 10005456, 10007377, 10002997, 10006737, 10004372, 10002841, 10005613, and 10002255.