—#207400

Product

Marlin 1.5T - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781474

FDA product code: LNH — System, Nuclear Magnetic Resonance Imaging
Device class: Class 2
Medical specialty: Radiology
Affected lot / code info: UDI-DI: N/A Serial Numbers: Serial Number 79113 79118 79127 79157 79122 79147 79105 79150 79152 79183 79192 79102 79108 79112 79115 79116 79153 79156 79162 79163 79164 79168 79188 79189 79100 79126 79179 79143 79159 79104 79132 79160 79182 79165 79107 79158 79175 79136 79138 79139 79184 79176 79180 79171 79172 79111 79125 79134 79135 79148 79177 79181 79173 79187 79190 79133 79110 79101 79117 79166 79124 79123 79130 79174 79178 79151 79114 79103 79106 79121 79128 79129 79137 79140 79155 79161 79167 79169 79170 79185

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 #207400. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.