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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 Philips see related information
Date Initiated by Firm May 03, 2024
Date Posted May 17, 2024
Recall Status1 Open3, Classified
Recall Number Z-1855-2024
Recall Event ID 94508
510(K)Number K063559  
Product Classification System, nuclear magnetic resonance imaging - Product Code LNH
Product Panorama HFO- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device.
Model Number (REF): 781350
Code Information UDI-DI: (1) 782152 N/A (2) 782110 (01)00884838099364(21) Serial Numbers: Serial Number 37019 37067 37149 37188 37184 37034 37036 37058 37167 37173 37183 37195 37197 37009 37011 37013 37020 37027 37031 37050 37055 37080 37093 37100 37121 37127 37132 37137 37141 37143 37150 37157 37170 37180 37193 37194 37023 37044 37066 37071 37106 37124 37160 37175 37182 37192 37022 37068 37082 37129 37134 37145 37156 37171 37181 37187 19083 37161 37178 37088 37024 37098 37135 37139 37176 37153 37060 37116 37196 37015 37073 37109 37122 37133 37162 37185 37026 37096 37177 37002 37012 37017 37029 37039 37041 37047 37048 37052 37053 37056 37077 37083 37084 37086 37087 37095 37102 37104 37107 37110 37113 37120 37123 37125 37128 37130 37136 37142 37158 37159 37163 37165 37168 37189 37069 37174 37126
Recalling Firm/
Manufacturer		 Philips North America Llc
222 Jacobs St
Cambridge MA 02141-2289
For Additional Information Contact Customer 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
Action Philips 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 Commerce 118 units
Distribution Worldwide 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 Cycle TPLC 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) Database 510(K)s with Product Code = LNH and Original Applicant = PHILIPS MEDICAL SYSTEMS
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