Philips Panorama MR System Structural Failure Risk from Helium Gas Pressure
Philips Panorama 1.0T MR Systems (Models 781250, 781350) may experience structural failure during helium quench events, releasing pressurized gas and debris that could cause helium exposure, asphyxia, and injury to patients and operators.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification requires minimum severity score of 4. While no injuries have been reported, the structural nature of the defect and potential for serious harm (chemical exposure, asphyxiation, debris trauma) during normal operation warrant the Severe classification.
Plain-English summary
Philips has recalled the Panorama 1.0T HFO Magnetic Resonance (MR) System, Models 781250 and 781350. This diagnostic imaging device is used in medical facilities for patient scanning and analysis.
The recall was initiated after the manufacturer identified a structural integrity problem in MR system components. During magnet quench operations, excessive pressure from helium gas can build up inside the system. If the system cannot contain this pressure safely (for example, due to an unexpected blockage), the structural components may fail and rupture, releasing pressurized helium gas.
If structural failure occurs, patients and staff at the facility may be exposed to chemical hazards from released helium gas, which can expand into surrounding areas. The rupture can also cause contusion injuries from debris. Helium release can lead to asphyxiation. The risk of serious injury or death applies to both patients and operators of the MR system.
Facilities with affected MR systems should contact Philips North America LLC, the recalling firm, for guidance on remediation. All serial numbers of the two affected models are included in this recall. Do not operate the system until you receive further instructions from the manufacturer.
The recalled product
- Product
- Panorama 1.0T HFO, Magnetic Resonance (MR) System; Model Numbers 781250 and 781350. Philips Magnetic Resonance (MR) systems are Medical Electrical Systems for use as a diagnostic device.
- Manufacturer
- Philips North America Llc
- Category
- Medical Device
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All serial numbers
Distribution
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