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Philips Warns MRI Customers of Potential Explosion
Philips customers should stop using the Panorama 1.0T HFO MRI system pending a field service inspection.
December 22, 2023
2 Min Read
Philips stopped making the Panorama 1.0T HFO MRI systems in 2014, but about 340 of the MRI machines are still in use globally.Image courtesy of Philips via FDA
At a Glance
- The impacted MRI systems were distributed between Jan. 1, 2001 and Oct. 1, 2016.
- There has been one reported event of an explosion in 22 years of use.
- A Philips field service engineer will inspect all impacted systems in the United States.
A risk of explosion has prompted Philips North America to recall its Panorama 1.0T HFO MRI systems.
The magnet in the MRI system may experience an unintended quench during normal use or when initiated in an emergency by the operator pressing the magnet "emergency stop" button.
During a magnetic quench, which is not common, a large amount of helium evaporates and is vented outside the building through a venting system, according to the FDA Class I recall notice. If an unknown blockage is present in the venting system and the pressure exceeds design limits, the structural integrity of the system could be compromised.
The use of an affected system may cause serious adverse health consequences, including chemical exposure, lack of oxygen, tissue damage, and mechanical trauma caused by debris, such as brain injury, laceration, fracture, eye injury, bruises, and death. The issue could also lead to system or property damage.
There has been one reported explosion in 22 years of use. There have been no reports of injury or death, according to Philips. In an email sent to MD+DI and other media outlets, the company said the one reported explosion occurred during a decommissioning magnet quench procedure where Philips guidelines were reportedly not followed.
Philips said all U.S. customers have been notified and about 80% of the systems have already been inspected. Outside the United States, about 85% of customers with operational unites have been contacted and about 75% of the systems have been inspected.
Philips launched the Panorama 1.0T HFO MRI system in 2005 and stopped selling the product line in 2014. There are about 340 Panorama units still in use globally, of which 150 are in the United States.
If your facility is impacted by this recall
Immediately discontinue use of any impacted MR system(s).
Do not initiate a manual quench of the magnet, unless there is an emergency
Post a “do not use” notice on or near the impacted MR system(s)
Post the FDA recall notice near the affected system(s) for ease of reference
Circulate the recall notice to all users of the device
Complete and return the customer response form to Philips no later than 30 days from receipt of the recall letter
U.S. customers with questions about the recall should call 1‐800‐722‐9377.
Philips said it will send a field service engineer to visit all U.S. customers impacted by the recall. The engineer will inspect the system and perform corrective replacement or repairs, if necessary.
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