Philips recalling MRI coils amid concern they could overheat and burn patients
Philips North America is recalling certain MRI coils amid concern they could overheat and cause second- or third-degree burns, the U.S. Food and Drug Administration said Friday.
The safety notice applies to the Sense XL Torso Coil 1.5T and 3T, which are 16-element, receive-only products used in imaging of the abdomen via Philips’ MR Intera and Achieva systems. This is a Class 1 recall, the FDA’s most serious designation, meaning these devices have the potential to cause “serious injuries or death.”
Philips first started alerting customers about the issue on May 31. It estimates that the issue impacts about 1,050 units worldwide, with the Amsterdam-based company discontinuing the first-generation Sense XL in 2014. Providers have submitted 64 complaints as of April 2024, including 52 reports of patient harm.
“Should this issue occur, affected coils may undergo localized heating during a scan. In this event, there is a possibility of patient injury from excessive heat,” Philips said in a statement sent to media on Friday. “Affected units may continue to be used in accordance with device instructions for use and the notification letter. In addition to the field safety notice, Philips anticipates providing an update to customers regarding a projected correction by the end of 2024.”
The recall only impacts about 307 units (with Philips’ safety notice focused on 1.5T and 3T coils, while the FDA update only mentioned the latter). Imaging providers are instructed to avoid first level operating mode/high specific absorption rate scans and use dedicated pads/mattresses provided with the coils. Philips also said to avoid positioning the coil closer than 2 inches from the MRI bore and do not exceed 45 minutes of examination time. Currently, the company is developing field corrections that include potential software risk control measures to limit scan settings, hardware updates and improving the coil’s design.
“Please be assured that maintaining a high level of safety and quality is our highest priority,” Philips Quality Leader Roxanne Ramirez said in an “urgent” safety notice issued May 31.
Marty Stempniak has covered healthcare since 2012, with his byline appearing in the American Hospital Association's member magazine, Modern Healthcare and McKnight's. Prior to that, he wrote about village government and local business for his hometown newspaper in Oak Park, Illinois. He won a Peter Lisagor and Gold EXCEL awards in 2017 for his coverage of the opioid epidemic.