FDA alerts to Class I recall of Panorama 1.0T HFO due to risk of serious injury or death during quench procedure

The FDA is warning consumers that the Panorama 1.0T HFO, initially recalled by Philips North America LLC on November 20, 2023, has since been labeled Class I, the most serious type of recall, due to risk of serious injury or death.

A magnetic resonance (MR) system, the Panorama 1.0T is a machine indicated to capture a variety of images inside the human body, which allows healthcare professionals to determine a diagnosis.

Officials took action after discovering that use of the device during a quench procedure may cause helium gas to arrive at an excessive pressure buildup, posing a risk of explosion.

While a quench is not commonly performed, the procedure involves a large amount of helium evaporating and being released “outside the building through a venting system.” In the event that the venting system contains a blockage, the pressure could become too great for the device’s design limits and damage the system’s structural integrity. In this case, the Panaorama 1.0T HFO’s magnet could also undergo an unexpected quench when being used normally, or when prompted by the user during an emergency via the Magnet button marked “EMERGENCY STOP.”

Affected Panorama 1.0T HFO devices may lead to a range of adverse health outcomes that include “chemical exposure, lack of oxygen, tissue damage,” as well as various mechanical trauma brought on by debris, including “brain injury, laceration, fracture, eye injury, bruises, and death.” Users should not that risks could also extend to “system or property damage.”

Throughout the 22 years that the Panorama 1.0T HFO has been in use, Philips North American LLC has received one report of an explosion. To date, the company has not been alerted to any instances of injury or death.

As identified in the FDA announcement, those to whom the recall should primarily concern are healthcare providers who work with the system for detailed, images or measurements of the interior of the head, body, or limbs from multiple perspectives. Use of an affected device also presents a risk to other people in its immediate vicinity.

Philips North America LLC has since identified all affected customers and warned them of the issue via an Urgent Medical Device Correction. Customers were asked to heed the following:

  • Identify any impacted MR systems and immediately cease all use.
  • Barring an emergency, avoid performing a manual quench of the magnet.
  • Label the impacted MR system with a “Do not use” notice.
    • For easy reference, this notice should be posted near the impacted Panorama 1.0T HFO system.
  • Spread awareness by ensuring that the Urgent Medical Device Correction is sent to all users who use the device. All users should be alerted to the product issue, as well as the inherent hazard and harm.
  • Fill out and mail Philips a customer response form within 30 days of receiving the letter.

Officials noted that customers within the U.S. should expect to be contacted by a Philips field service engineer who will perform an inspection of the system and corrective replacement or repairs as needed.

U.S. customers may direct recall-related questions to Philips’ Customer Care Solutions Center at 1-800-722-9377.


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