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Z-0505-2024 Class I Ongoing

Recalled by Philips North America Llc — Cambridge, MA

FDA device recall Z-0505-2024 was initiated by Philips North America Llc on November 17, 2023 and is designated Class I. Reason for recall: 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 u… The recall status is ongoing. Affected quantity: 150 US; 192 ROW.

Recall Details

Product Type: Devices
Report Date: December 20, 2023
Initiation Date: November 17, 2023
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 150 US; 192 ROW

Product Description

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.

Reason for Recall

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.

Distribution Pattern

Domestic distribution to 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 International distribution to Argentina Austria Canada China Colombia Croatia Czech Republic Denmark Ecuador Egypt France Germany Greece Italy Kuwait Libya Netherlands NO93 Panama Poland Portugal Qatar Russian Fed. Saint Kitts Saudi Arabia Spain Sweden Switzerland Syria Thailand T¿rkiye United Kingdom Utd.Arab.Emir. Venezuela

Code Information

All serial numbers

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