Device product
IMRIS ORT 200, Removable Operating Room Table, Part Numbers: (a) 113821-000, (b) 113821-600, (c) 114148-000, (d) 114148-600 - 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-0647-2019
Product summary
- Event
- Event 81574
- Status
- Terminated
- Classification
- Class II
- Quantity
- 14 units
- Official record key
device-enforcement:Z-0647-2019
Official wording
Reason: Table may drift in the roll position while in use
Code information: (a) 113821-000, Serial Numbers: 10002220 (b) 113821-600, Serial Numbers: 10002692, 10006152, 10007192, 10006991, 10003754, 10006997, 10004513 (c) 114148-000, Serial Numbers: 10004463, 10005190, 10005189, 10006891, 10004997 (d) 114148-600, Serial Numbers: 10006891
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