Devices

Device Recall Philips Ingenia 1 .5T and Ingenia 3.OT MR systems

Model / Serial
781437: 15001, 15002, 15003 781438: 30001, 30002, 30003, 30004, 30005, 30006
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution -US including CA, NY and Internationally to United Kingdom, Australia, Norway, and Thailand
Product Description
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
Manufacturer
Philips Electronics North America Corporation
1 Event
- Recall of Device Recall Philips Ingenia 1 .5T and Ingenia 3.OT MR systems

Manufacturer

Philips Electronics North America Corporation

Manufacturer Address
Philips Electronics North America Corporation, 3000 Minuteman Rd, Andover MA 01810-1032
Manufacturer Parent Company (2017)
Philips
Source
USFDA

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