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.
This recall is currently active, issued December 14, 2023. It was issued by Philips North America Llc.
- Company
- Philips North America Llc
- Recall Initiated
- November 17, 2023
- Posted
- December 14, 2023
- Recall Number
- Z-0505-2024
- Quantity
- 150 US; 192 ROW
- Firm Location
- Cambridge, MA
- Official Source
- View on FDA website ↗
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
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
Lot / Code Info
All serial numbers
Root Cause
Component design/selection
Action Taken
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).