medical Class I Updated 2023-12-20

Philips North America Llc recalls Panorama 1.0T HFO, Magnetic Resonance (MR) System; Model Num

Recalled 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.

Hazard / Issue

Firm was informed of an event in which the structural integrity of the MR system components failed due to unintended excessive pressure buildup of helium gas during a magnet quench. If the system is unable to contain the pressured helium gas due to an unforeseen blockage in the system, risks to patients and/or operators that may lead to injury or death include chemical exposure (i.e. helium gas) that may expand to surrounding rooms, contusion caused by debris, and asphyxia.

Issued by

FDA

Affected States: AL, AZ, CA, CO, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MO, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, WV
Lot/Code Info: All serial numbers
View official government recall

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