Device product
IMRIS ORT 300, Removable Operating Room Table, Part Numbers: (a) 114093-000, (b) 114093-006 - Product Usage: The ORT200 and ORT300 are intended for use during diagnostic examinations, radiologic procedures, or surgical procedures to support and position a patient. The tables are indicated for imagining from head to sacrum with MR/CT imaging modalities. The ORT100 table is intended for use during diagnostic examination or surgical procedures to support and position the patient.
Z-0648-2019
Product summary
- Event
- Event 81574
- Status
- Terminated
- Classification
- Class II
- Quantity
- 14 units
- Official record key
device-enforcement:Z-0648-2019
Official wording
Reason: Table may drift in the roll position while in use
Code information: (a) 114093-000, Serial Numbers: 10005695, 10002998, 10005456, 10007377, 10002997, 10005612, 10004372, 10002841 10002255, 10002385, 10005613 (b) 114093-006, Serial Numbers: 10007411, 10002996, 10004515
Distribution pattern: Worldwide distribution - US Nationwide and countries of China, Qatar, Canada, Australia, Japan, France, Germany, Sweden, Italy.
Derived failure modes
-
Unknown
Table may drift in the roll position while in use