—#207399

Product

Panorama HFO- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781350

FDA product code: LNH — System, Nuclear Magnetic Resonance Imaging
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K063559
Affected lot / code info: 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

Why it was recalled

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

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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

Recalling firm

Firm: Philips North America Llc
Address: 222 Jacobs St, Cambridge, Massachusetts 02141-2289

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2024-05-03
Posted by FDA: 2024-05-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #207399. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.