FDA issues update on MRI coil recall
On Monday, the U.S. Food and Drug Administration issued an update related to its recent recall of Philips’ MRI coils.
In May, Philips alerted its customers about concerns that the company’s Sense XL Torso (1.5T and 3T) coils could overheat and cause patients to sustain serious burns. In a letter sent to customers, Philips noted that complaints and reports of patient harm related to the coils overheating are what triggered the safety alert. Between 2011 and 2024, there have been 64 complaints and 52 reports of injuries, according to Philips.
“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 in June. “Affected units may continue to be used in accordance with device instructions for use and the notification letter.”
Although the coils in question were discontinued in 2014, many facilities still utilize them. As such, a Class 1 recall, which is the FDA’s most serious type due to the potential for serious harm, was issued in June. The recall does not require the devices to be removed from where they are used or sold but does provide detailed instructions for facilities that still use the coils.
In this most recent alert, the FDA shared the following instructions from Philips:
Continue using the coils in accordance with the updated instructions for use, which affected customers should have already received.
Avoid first level operating mode/high SAR scans when using the coils.
Always use the padding that was provided with the coils.
In the safety alert sent to affected customers in May, Philips offered the following advice for facilities still using the coils:
Avoid positioning the coil close to the bore, ensuring the anterior portion of the coil is at least 2 inches (5 cm) away from the bore.
Make sure that exams for a single patient do not exceed 45 minutes.
Although there have been several serious accidents involving MRI scanners that have made headlines in recent years, burns are the most common injury during MR imaging. According to the FDA, between 2008 and 2017, burns accounted for 59% of MRI safety events.
Philips expects to provide another update on the actions being taken to remedy the issue by the end of 2024.
For more information on the recall, click here.
In addition to her background in journalism, Hannah also has patient-facing experience in clinical settings, having spent more than 12 years working as a registered rad tech. She joined Innovate Healthcare in 2021 and has since put her unique expertise to use in her editorial role with Health Imaging.