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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-1845-2024
Recall Event ID 94508
510(K)NumberK193215 
Product Classification System, nuclear magnetic resonance imaging - Product Code LNH
ProductIngenia 1.5T Model Number (REF): (1) 782140; (2) 782115; (3) 782101; (4) 781396; (5) 781341; (6) 781315
Code Information UDI-DI: (1) 782140 (01)00884838108646(21); (2) 782115 (01)00884838099043(21); (3) 782101 (01)00884838098275(21); (4) 781396 (01)00884838009820(21); (5) 781341 (01)00884838055322(21); (6) 781315 (01)00884838099715(21); Serial Numbers: 61019 61140 61080 61067 61091 61114 61028 61039 61040 61041 61000 61002 61003 61006 61009 61013 61017 61032 61058 61065 61066 61074 61075 61076 61097 61106 61124 61060 61001 61004 61008 61011 61023 61025 61026 61034 61035 61042 61046 61054 61055 61062 61063 61115 61078 61015 61119 61005 61020 61043 61085 61087 61088 61029 61030 61033 61036 61037 61045 61051 61052 61057 61061 61064 61068 61069 61070 61072 61095 61123 61116 61117 61125 61126 61129 61130 61027 61108 61109 61131 61144 61107 61138 61142 61143 61102 61103 61007 61014 61018 61016 61038 61073 61079 61024 61031 61059 61082 61084 61092 61093 61096 61101 61022 61044 61047 61049 61050 61053 61056 61094 61105 61112 61132 87260 70040 70229 70607 70763 84030 84108 84126 84234 84257 84596 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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 Commerce2262 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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