Device product
Ingenia MR-OR; 781437, 781438 The MR-OR option is intended for allowing transfer of a neurosurgical patient from OR suite to MR suite and back with tools and instructions for proper positioning and MR imaging of those patients. MR-OR option also facilitates execution of simple neurosurgical procedures in the near proximity of the MR scanner without a need to move the patient back to the OR suite
Z-0825-2017
Product summary
- Event
- Event 75844
- Status
- Terminated
- Classification
- Class II
- Quantity
- 9
- Official record key
device-enforcement:Z-0825-2017
Official wording
Reason: Possibility that a patient or user may be exposed to a very small level of touch current.
Code information: 781437: 15001, 15002, 15003 781438: 30001, 30002, 30003, 30004, 30005, 30006
Distribution pattern: Worldwide Distribution -US including CA, NY and Internationally to United Kingdom, Australia, Norway, and Thailand
Derived failure modes
-
Unknown
Possibility that a patient or user may be exposed to a very small level of touch current.