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
Reported: December 28, 2016 Initiated: December 1, 2016 #Z-0825-2017
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
Reason for Recall
Possibility that a patient or user may be exposed to a very small level of touch current.
Details
- Recalling Firm
- Philips Electronics North America Corporation
- Units Affected
- 9
- Distribution
- Worldwide Distribution -US including CA, NY and Internationally to United Kingdom, Australia, Norway, and Thailand
- Location
- Andover, MA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Philips Electronics North America Corporation. Units affected: 9.
Why was this product recalled? ▼
Possibility that a patient or user may be exposed to a very small level of touch current.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 28, 2016. Severity: Moderate. Recall number: Z-0825-2017.
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