Philips North America Llc Recall 88461
Description: Ingenia 3.0T-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body or extremities Model Number: 781342
Philips North America Llc Recall 88461 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2343-2021 |
| Event ID | 88461 |
| Event Description | Ingenia 3.0T-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body or extremities Model Number: 781342 |
| Product Type | Devices |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, MD, MD, NH, NY, OH, TN, TX, VA and the countries of Canada, Mexico, Australia, Austria, Chile, China, Czech Republic, Denmark, France, Germany, India, Indonesia, Italy, Japan, Korea, Republic of Lebanon, Netherlands, Romania, Russian Federation, Saudi Arabia, Spain, Turkey, Ukraine, United Kingdom. |
| Quantity | 3 units US; 17 units OUS |
| Recall Reason | Pressure relief valve 42 psi installed in the magnet assembly instead of a 3.75 psi valve, may result in release of helium gas and cause injury |
| Device Classification | 20210901 |
| Device Code Info | S/N and UDI: 85275 (01)00884838055339(21)85275; 85278 (01)00884838055339(21)85278; 85394 (01)00884838055339(21)85394. OUS: 85393 (01)00884838055339 85332 (01)00884838055339 85334 (01)00884838055339 85336 (01)00884838055339 85349 (01)00884838055339 85350 (01)00884838055339 85355 (01)00884838055339 85370 (01)00884838055339 85371 (01)00884838055339 85382 (01)00884838055339 85384 (01)00884838055339 85385 (01)00884838055339 85398 (01)00884838055339 85348 (01)00884838055339 85149 (01)00884838055339 85367 (01)00884838055339 85388 (01)00884838055339 |
| Center Classification Date | 20210825 |
| Recall Initiation Date | 20210730 |
| Recalling Firm | Philips North America Llc |
| Similar To |