Recall Z-1024-2016 ยท LNH System, Nuclear Magnetic Resonance Imaging
Philips Electronics North America Corporation
SENSE Body Coil 1.5T with identification; used in the ACS NT, Intera 1.5T and Achieva 1.5T MR system
| Date | Feb 26, 2016 (initiated Jul 6, 2015) |
| Status | Terminated |
| Reason | Wrong positioning of the coil cables can create unintended resonances via the patient or elevated coil cable temperature due to coupling to the QBC. The combined use of the Sense coil, high SAR level scanning and placement of the cables contrary to instructions for use can lead to patient burns. |
| Root cause | Device Design |
| Action | On 6/18/2015, the Field Safety Notice / Medical Device Correction Notice was sent to customers via certified mailing. The letter explains the issue and provides user instructions. A sleeve is being developed that will be applied to the cable on the Sense Body Coil 1.5T and provide consistent spacing between the cable and the patient, thereby reducing the chance of RF interaction and heating. This sleeve will be distributed as part of a Field Change Order with reference FCO781 00437 for Sense Body Coils in the installed base and will be installed by the Philips Field Service Engineers. |
| Quantity | 5672 |
| Distribution | US: Nationwide OUS: Canada, Afghanistan Albania Algeria Andorra Argentina Australia Austria Azerbaijan Bahamas Bangladesh Belarus Belgium Bolivia Bosnia and Herzegovina Botswana Brazil Burkina Faso Chile China Colombia Columbia Congo, Democratic Costa Rica Croatia Cyprus Czech Republic Denmark Domin |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K001796 | GYROSCAN INTERA (R7.5) Philips Medical Systems North America, Inc., Sep 6, 2000 |
| K013344 | INTERA I/T Philips Medical Systems North America Co., Dec 11, 2001 |
| K030520 | INTERA FAMILY Philips Medical Systems North America Co., Mar 6, 2003 |
| K945945 | GYROSCAN ACS-NT, GYROSCAN T5-NT AND GYROSCAN T10-NT Philips Medical Systems North America, Inc., Dec 22, 1995 |