Recall Z-2461-2010 ยท MOS Coil, Magnetic Resonance, Specialty
Philips Medical Systems North America Co. Phillips
Nuclear Magnetic Resonance Imaging System (MRI). Trace item 9896-030-14351 -1.5T Sense XL Torso coil 12nc on coil: 4535-671-4188x.
| Date | Sep 22, 2010 (initiated Sep 30, 2008) |
| Status | Terminated |
| Reason | The cables of the coil may become too hot and cause burns when placed too close to the patient. While using the 1.5T Sense XL Torso coil, unwanted radiofrequencies (RF) interaction with the patient can occur. Especially in combination with high SAR levels and when the RF cables of the coil are too close to the patient, this RF interaction has resulted in RF burns to patients. |
| Root cause | Other |
| Action | Philips Healthcare issued URGENT-Device Correction Notices dated September 30, 2008 to their consignees. The notice identified the recalled device as 1.5 Intera and 1.5T Achieva MRI systems, described the risk to patients, and the actions to be taken by customers.. The firm has issued Field Change Order (FCO) 78100242. Field service representatives will visit each consignee and conduct a hardware upgrade, applying a sleeve over the cable that will ensure proper spacing between the cable and patient, reducing the chance of RF interaction and burns. The consignees should contact the Philips Ca |
| Quantity | 47 units total (Achieva 1.5T and Intera 1.5T) |
| Distribution | Nationwide Distribution: Throughout USA. No distribution to foreign consignees. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052013 | ACHIEVA 1.5T & INERA 1.5T FAMILY Philips Medical Systems Nederland B.V., Aug 2, 2005 |