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.
Recall
- Recall Number
- Z-0505-2024
- Event Number
- 93454
- Firm
- Philips North America Llc
- FEI Number
- 3016618143
- Product Code
- LNH
- Status
- Open, Classified
- Root Cause
- Component design/selection
- Initiated
- November 17, 2023
- Posted
- December 14, 2023
- Address
- 222 Jacobs St, Cambridge, MA, 02141-2289
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.
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.
On November 17, 2023, the firm issued an URGENT Medical Device Correction letter to affected consignees. Customers were provided instructions on how to identify impacted systems. Customers with impacted systems should immediately discontinue use of their impacted MR system. Philips is requesting that customers immediately stop using the MR systems until an inspection can be completed. Philips will contact customers to schedule an on-site visit by a Field Service Engineer to inspect your system starting in December 2023. If you need any further information or support concerning this issue, please contact your local Philips representative: For North America, contact the Customer Care Solutions Center (1-800-722-9377).
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150 US; 192 ROW