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U.S. Department of Health and Human Services

Class 2 Device Recall Philips

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 Class 2 Device Recall Philipssee related information
Date Initiated by FirmMay 03, 2024
Date PostedMay 17, 2024
Recall Status1 Open3, Classified
Recall NumberZ-1847-2024
Recall Event ID 94508
510(K)NumberK193215 
Product Classification System, nuclear magnetic resonance imaging - Product Code LNH
ProductIngenia 1.5T S Model Number (REF): 781347
Code Information UDI-DI: (01)00884838068421(21) Serial Numbers: 81003 81050 81051 81090 81111 81010 81027 81028 81030 81035 81063 81106 81093 81105 81116 81007 81004 81006 81009 81011 81016 81017 81018 81019 81020 81023 81024 81031 81037 81041 81055 81056 81057 81060 81062 81064 81070 81074 81078 81112 81115 81122 81146 81147 81153 81156 81158 81013 81044 81040 81047 81059 81167 81170 81171 81008 81108 81148 81133 81164 81001 81086 81079 81118 81138 81139 81140 81151 81175 81184 81069 81061 81065 81098 81085 81091 81092 81032 81043 81129 81131 81149 81155 81162 81165 81172 81180 81084 81087 81088 81094 81095 81100 81127 81132 81174 81157 81176 81071 81052 81067 81039 81038 81179 81185 81117 81173 81154 81025 81097 81152 81015 81029 81033 81034 81042 81046 81048 81049 81058 81072 81080 81103 81113 81123 81128 81137 81045 81075 81076 81077 81096 81114 81124 81126 81145 81159 81178
Recalling Firm/
Manufacturer		 Philips North America Llc
222 Jacobs St
Cambridge MA 02141-2289
For Additional Information ContactCustomer Care Solution Center
800-722-9377
Manufacturer Reason
for Recall		The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire
FDA Determined
Cause 2		Under Investigation by firm
ActionPhilips issued Urgent Medical Device Correction notifications to customers on 22-Apr-2024 via FedEx . Philips Markets Organizations are responsible for distributing the letters outside of the US. Letter states reason for recall, health risk and action to take: If a smoke/fire alarm is detected: a. Immediately stop scanning and evacuate the patient and staff from the examination room. b. If a developing fire is detected, adhere to established hospital fire emergency procedures, which may include switching off power to the complete system and/or removing the magnet field by using the Emergency Magnet Off button. c. Do not attempt to continue scanning. d. Immediately contact Philips Service. " Ensure all users are aware of facility specific Emergency Procedures as outlined in Chapter 2: Safety in the Instructions for Use Emergency procedures The User is required to establish emergency procedures for the following situations: " A medical emergency " A fire " An emergency that requires immediate removal of the magnetic field " The release of helium gas into the examination room Philips MRI systems have an Emergency Table Stop button in case there is an emergency during tabletop movement. " Circulate this Urgent Medical Device Correction Letter to all users of this device so that they are aware of the issue. " Post this notice near the affected MR system(s) for ease of reference. Please complete and return the attached response form to Philips promptly and no later than 30 days from receipt via email to: pd.cnr@philips.com. Completing this form confirms receipt of the Urgent Medical Device Correction Letter, understanding of the issue, and required actions to be taken. 5. The actions planned by Philips to correct the problem Philips will contact you to schedule time for a Field Service Engineer (FSE) to visit your site to inspect the g-MDU connections in the technical room and apply the proper torque to the connection if necessary.(reference FCO78100582). Philips plans t
Quantity in Commerce139 units
DistributionWorldwide distribution - US Nationwide and the countries of Austria, Belgium, Canada, China, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Italy, Japan, Lebanon, Libya, Lithuania, Martinique, Netherlands, Norway, Poland, Romania, Slovakia, Spain, Sweden, Switzerland, Thailand, United Kingdom.
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
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