News | Magnetic Resonance Imaging (MRI) | December 20, 2023

The FDA has identified this as a Class I recall, the most serious type of recall

The FDA has identified this as a Class I recall, the most serious type of recall

The FDA has identified this as a Class I recall, the most serious type of recall.


December 20, 2023 — According to the U.S. Food and Drug Administration (FDA), Philips North America LLC is recalling Panorama 1.0T HFO, a magnetic resonance imaging (MRI) system, due to a risk of explosion during a quench procedure caused by excessive pressure buildup of helium gas. During a quench, a large amount of helium evaporates and is vented outside the building. 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 FDA has identified this as a Class I recall, the most serious type of recall. Please be aware, this recall is a correction, not a product removal. Use of these devices may cause serious injuries or death.

Recalled Product 

  • 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 (MR) system, a machine used to take different kinds of images. These images show what's inside the body and can help health care providers make a diagnosis.

Reason for Recall  

Philips North America LLC is recalling the Panorama 1.0T HFO due to risk of explosion during a quench procedure caused by excessive pressure buildup of helium gas.

During a quench, which is not common, a large amount of helium evaporates and is vented outside the building through a venting system. 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 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.

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 event of an explosion in 22 years of use. There have been no reports of injury or death.

Who May be Affected 

  • Health care providers who use the Panorama 1.0 system to obtain detailed pictures or measurements of the inside of the head, body, or limbs from different angles.
  • People in the vicinity of the system when such an incident takes places. 

What to Do 

On November 20, 2023, Philips North America LLC sent all affected customers an URGENT Medical Device Correction notice.

The letter requested customers to: 

  • Immediately discontinue use of any impacted MR system(s).
  • 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 this notice near the affected Panorama 1.0T HFO system(s) for ease of reference.
  • Circulate this notice to all users of this device so that they are aware of the product issue and associated hazard/harm until this issue has been resolved.
  • Complete and return the updated customer response form to Philips no later than 30 days from receipt of this letter.

All U.S. customers will be visited by a Philips field service engineer who will inspect the system and perform corrective replacement or repairs, if necessary.

Contact Information 

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

Additional Resources: 

How do I report a problem?

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


Related Content

News | PET Imaging

May 29, 2026 — GE HealthCare recently announced that its MIM KineticID modeling software1 is now 510(k) pending with the ...

Time May 29, 2026
arrow
News | Radiopharmaceuticals and Tracers

May 27, 2026 — Subtle Medical has received FDA clearance for its SubtleHD (PET), the company's next-generation AI ...

Time May 27, 2026
arrow
News | Radiology Business

May 22, 2026 — The American College of Radiology (ACR) supports passage of the Medicare Access to Radiology Care Act (S ...

Time May 26, 2026
arrow
News | Radiology Business

May 22, 2026 — U.S. Sens. Boozman, R-AR, and Luján, D-NM, have introduced the Medicare Access to Radiology Care Act ...

Time May 26, 2026
arrow
News | Cardiac Imaging

May 21, 2026 — A team of researchers from Carnegie Mellon University, in collaboration with Cleveland Clinic’s ...

Time May 22, 2026
arrow
News | X-Ray

May 21, 2026 — RADIN Health and AZmed have announced the expansion of their strategic partnership and enhance radiology ...

Time May 22, 2026
arrow
Feature | Enterprise Imaging | Kyle Hardner

For radiology departments, the imbalance between surging imaging volume and a shortage of trained radiologists is taking ...

Time May 20, 2026
arrow
News | Radiology Imaging

May 18, 2026 — DICO, a company specializing in the creation of distributed diagnostic infrastructure for radiology, has ...

Time May 19, 2026
arrow
News | Interventional Radiology

May 12, 2026 — Siemens Healthineers has received clearance from the Food and Drug Administration for six new systems in ...

Time May 12, 2026
arrow
News | Magnetic Resonance Imaging (MRI)

May 11, 2026 – At the International Society for Magnetic Resonance in Medicine (ISMRM) 2026 Annual Meeting, GE ...

Time May 11, 2026
arrow
Subscribe Now