Philips has initiated a recall for several models of its Sense XL Torso coils utilized in MRI machines due to the potential for these devices to overheat, posing a risk of burns to patients during MRI scans. The recall impacts six models of the Sense XL Torso coils that are compatible with both 1.5T and 3.0T MRI scanners. The Food and Drug Administration (FDA) disclosed this information in a notice published on Monday, indicating that while the recall does not demand the removal of the products from medical facilities or sales venues, it does require updated usage instructions for these devices.
According to the FDA, there have been twelve reported incidents of injuries related to the recalled coils. Fortunately, there have been no deaths associated with this issue. Philips, the manufacturer, has been navigating numerous safety concerns over recent years, notably including a significant recall involving over 15 million of their respiratory devices which has been ongoing for more than three years. Additionally, the company faced problems in November when certain MRI scanners were recalled because of the danger of the machines exploding. This was following a single reported explosion incident in the 22 years of the system’s operation.
Earlier in the year, in February, Philips received a warning letter from the FDA after an inspection revealed that three adjustments made to computed tomography machines had not been reported as required. Philips started this most recent recall concerning the MRI coils on June 5, affecting over 1,000 devices distributed across various global locations. The company had already begun notifying its customers of these developments on May 31.
The recalled Sense XL Torso coils are specifically designed for creating MRI images of the torso and abdomen. The newly issued instructions now advise against placing the coils too close to the machine’s central bore and recommend not exceeding a usage duration of 45 minutes per examination. Additionally, Philips has instructed facilities to use specific pads and mattresses designed to accompany the coils, reinforcing safety during their use.
The FDA has categorized this recall as a Class I event, its most serious classification. This classification is applied due to the associated risk of significant patient injuries, including serious burns or even death, should the recalled devices malfunction. This recall highlights ongoing challenges Philips faces in ensuring the safety and reliability of its imaging and respiratory devices, with the added burden of managing multiple product recalibrations and retracting units from an extensive range of medical hardware.
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