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Philips has recalled several Sense XL Torso coil models due to overheating risks during MRI scans, which can cause patient burns. An FDA recall notice issued Monday updated instructions for six models used with 1.5T and 3.0T MRI scanners. The recall does not require removing the products from facilities.
The FDA reported 12 injuries but no deaths linked to the recall. This adds to Philips' safety issues, including a three-year recall of over 15 million respiratory devices. In November, Philips recalled some MRI scanners due to explosion risks, with one incident reported in 22 years. An FDA warning letter in February followed unreported field corrections in CT machines.
The June 5 recall affects over 1,000 devices globally, with customer notifications sent on May 31. Philips advised avoiding coil positioning near the machine’s bore, limiting exams to 45 minutes, and using provided pads and mattresses. The FDA classified the recall as Class I, indicating serious injury or death risks.
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