Device product
IMRIS T2X table, Part Numbers: (a)108000-000, (b)108000-600, (c)109682-000, (d) 109682-600, (e) 110470-600 - 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-0645-2019
Product summary
- Event
- Event 81574
- Status
- Terminated
- Classification
- Class II
- Quantity
- 15 units
- Official record key
device-enforcement:Z-0645-2019
Official wording
Reason: Table may drift in the roll position while in use
Code information: (a)108000-000, Serial Numbers: 10000983, 10000652 (b)108000-600, Serial Numbers: 06-0025, 10001306 (c)109682-000, Serial Numbers: 10002375, 10001118, 10001340 (d)109682-600, Serial Numbers: 10001119, 10001188, 10003634, 05-002, 10003638, 10003623, 10001305 (e)110470-600, Serial Numbers: 10006887
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