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U.S. Department of Health and Human Services

Class 1 Device Recall Panorama 1.0T HFO

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 Class 1 Device Recall Panorama 1.0T HFOsee related information
Date Initiated by FirmNovember 17, 2023
Date PostedDecember 14, 2023
Recall Status1 Open3, Classified
Recall NumberZ-0505-2024
Recall Event ID 93454
510(K)NumberK041602 K052078 K063559 
Product Classification System, nuclear magnetic resonance imaging - Product Code LNH
ProductPanorama 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.
Code Information All serial numbers
Recalling Firm/
Manufacturer		 Philips North America Llc
222 Jacobs St
Cambridge MA 02141-2289
Manufacturer 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.
FDA Determined
Cause 2		Component design/selection
ActionOn 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).
Quantity in Commerce150 US; 192 ROW
DistributionDomestic 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
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = LNH
510(K)s with Product Code = LNH
510(K)s with Product Code = LNH
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