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Class 2 Device Recall Philips |
![see related information](../images/related-info.gif) |
Date Initiated by Firm |
May 03, 2024 |
Date Posted |
May 17, 2024 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-1856-2024 |
Recall Event ID |
94508 |
Product Classification |
System, nuclear magnetic resonance imaging - Product Code LNH
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Product |
Marlin 1.5T - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781474 |
Code Information |
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
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Recalling Firm/ Manufacturer |
Philips North America Llc 222 Jacobs St Cambridge MA 02141-2289
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For Additional Information Contact |
Customer Care Solution Center 800-722-9377
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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
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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 |
81 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.
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Total Product Life Cycle |
TPLC Device Report
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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.
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