Device product
Operating room table - Product Usage: intended for use during diagnostic examinations, radiologic procedures or surgical procedures to support and position a patient.
Z-2585-2021
Product summary
- Event
- Event 88661
- Status
- Terminated
- Classification
- Class II
- Quantity
- 10 units
- Official record key
device-enforcement:Z-2585-2021
Official wording
Reason: ORT200/300 rotational lock may fail to function such that it cannot change states between locked and unlocked, due to a mechanical hardware issue.
Code information: UDI: 00857534006356 Model Number: 114093-000; Serial Numbers: 10005695, 10002998, 10005456, 10007377, 10002997, 10006737, 10004372, 10002841, 10005613, and 10002255.
Distribution pattern: Worldwide distribution - US Nationwide distribution FL, NH, TX, OH, CA, OR, UT, TN, NC and the countries of Canada, Australia, Sweden, Japan.
Derived failure modes
-
Unknown
ORT200/300 rotational lock may fail to function such that it cannot change states between locked and unlocked, due to a mechanical hardware issue.