Recall Z-0825-2017 ยท LNH System, Nuclear Magnetic Resonance Imaging
Philips Electronics North America Corporation
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
| Date | Dec 19, 2016 (initiated Dec 1, 2016) |
| Status | Terminated |
| Reason | Possibility that a patient or user may be exposed to a very small level of touch current. |
| Root cause | Device Design |
| Action | Philips sent an Urgent Field Safety Notice Medical Device Correction letter dated November 2016 to all affected customers. The letter explains the issue and actions planned by Philips. There is no need for action to be taken by customer or user. Customers with questions should contact their local Philips representative Technical Support Line 1-800-722-9377. |
| Quantity | 9 |
| Distribution | Worldwide Distribution -US including CA, NY and Internationally to United Kingdom, Australia, Norway, and Thailand |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110151 | ACHIEVA R4 1.5T AND ACHIEVA R4 3.0T Philips Health Care, Mar 22, 2011 |