Philips North America LLC Recalls Panorama 1.0T HFO Due to Risk of Explosion

Philips North America LLC has issued a voluntary recall for its Panorama 1.0T HFO magnetic resonance (MR) system due to a potential risk of explosion during a quench procedure caused by excessive pressure buildup of helium gas.

The U.S. Food and Drug Administration (FDA) has classified this recall as Class I, indicating the highest level of risk that the use of these devices may lead to serious injuries or death.

Recalled Product Information:

•          Product Names: Panorama 1.0T HFO

•          Product Codes: LNH

•          Model Numbers: 781250 and 781350

•          Distribution Dates: January 1, 2001, to October 1, 2016

•          Devices Recalled in the U.S.: 150

•          Date Initiated by Firm: November 20, 2023

Device Use: The Panorama 1.0T is a magnetic resonance system utilized for medical imaging. It provides detailed images of the inside of the body, aiding healthcare providers in diagnostics.

Reason for Recall: The recall is initiated due to the risk of explosion during a quench procedure caused by the excessive buildup of helium gas pressure. A quench is an infrequent occurrence during which a large amount of helium evaporates and is vented outside the building. If an unknown blockage occurs in the venting system, and the pressure exceeds design limits, the structural integrity of the system could be compromised.

The magnet in the Panorama 1.0T HFO may experience an unintended quench during normal use or when initiated in an emergency by the operator pressing the Magnet EMERGENCY STOP button. This issue poses serious health risks, including chemical exposure, lack of oxygen, tissue damage, and mechanical trauma.

Incident History: There has been one reported event of an explosion in 22 years of use, with no reported injuries or deaths.

Who May be Affected:

•          Health care providers using the Panorama 1.0 system for medical imaging.

•          Individuals in the vicinity of the system during an incident.

Actions to be Taken by Customers:

•          Immediately discontinue the use of any impacted MR system.

•          Do not initiate a manual quench of the magnet unless it is an emergency.

•          Post a “Do not use” notice on or near the impacted MR system.

•          Distribute the recall notice to all users of the device.

•          Complete and return the updated customer response form to Philips within 30 days.

Remedial Actions by Philips:

•          All U.S. customers will be visited by a Philips field service engineer for inspection and corrective replacement or repairs, if necessary.

Contact Information: Customers in the U.S. with questions about this recall should contact Customer Care Solutions Center at 1‐800‐722‐9377.

Additional Resources:

•          Medical Device Recall Database Entry

•          How do I report a problem?

•          Health care professionals and consumers may report adverse reactions or quality problems to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.

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