Recall Z-0293-2012 ยท LNH System, Nuclear Magnetic Resonance Imaging
Philips Medical Systems (Cleveland) Inc
Ingenia 1.5T and 3.0T MRI Systems, Model Numbers: 781396 and 781377, 510(k) #K110151. System units equipped with software version: 4.1.1 are subject to recall/field correction. This MRI system is indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities. Ima
| Date | Nov 28, 2011 (initiated Aug 3, 2011) |
| Status | Terminated |
| Reason | The firm determined that during scanning procedures, for some larger patients, some reddening of the skin of can occur in certain instances due to RF heating when the torso of the patient is positioned within the body coil. |
| Root cause | Software design |
| Action | Philips Medical Systems ( Cleveland) Inc. sent a Urgent Field Safety Notice dated August 3, 2011, to all affected customers. Philips Field Service Engineers were dispatched to the affected customer sites to deliver the recall notification and to perform the necessary software corrections. The letter lists the affected MRI systems; describes the problem; the actions to be taken by the customer/user; it also informs the customer of the upcoming software correction which will be applied to each unit by the Philips Field Service Engineers in order to address this issue. If any additional info |
| Quantity | 26 units - 12 units distributed in U.S. & 16 distributed to foreign customers |
| Distribution | Worldwide Distribution -- USA (nationwide) including the states of AL, AZ, CA, GA, OR, MI, NJ and TX., and the countries of AU, BE, CH, DE, FR, JP, NL and SE. |
| 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 |