Philips recall of imaging coils tied to 12 injuries
Dive Brief:
Philips has recalled several models of Sense XL Torso coils due to the risk of the devices heating up during MRI scans and burning patients.
Philips updated the instructions for six models of Sense XL Torso coils used with 1.5T and 3.0T MRI scanners, according to a recall notice posted Monday by the Food and Drug Administration. The recall does not require products to be removed from facilities or where devices are sold.
Twelve reported injuries have been associated with the recall, the FDA said. No deaths were reported.
Dive Insight:
Philips’ latest recall is yet another safety problem for the company, which has spent more than three years managing a recall of over 15 million respiratory devices.
The company has had recent issues with imaging machines. In November, Philips recalled certain MRI scanners because of the risk of machines exploding. The FDA said at the time that there had only been one report of a machine exploding in the 22 years the system had been in use.
In February, the agency also sent Philips a warning letter after an inspection last year found three unreported field corrections for computed tomography machines.
Philips initiated its latest recall for MRI coils on June 5, affecting more than 1,000 devices distributed worldwide. The company notified customers on May 31.
The coils are used for developing MRI images of the torso and abdomen. The updates to the instructions for use include avoiding positioning the coils close to a machine’s bore and not exceeding 45 minutes of examination time. The company also told customers to use dedicated pads and mattresses supplied with the coils.
The FDA labeled the recall as a Class I event, the most severe classification, due to the risk of patients being seriously burned or dying.
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