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Class 2 Device Recall Philips |
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Date Initiated by Firm |
May 03, 2024 |
Date Posted |
May 17, 2024 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-1846-2024 |
Recall Event ID |
94508 |
510(K)Number |
K193215
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Product Classification |
System, nuclear magnetic resonance imaging - Product Code LNH
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Product |
Ingenia 1.5T CX - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): (1) 781262 (2) 781261
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Code Information |
UDI-DI:
(1) 781262 (01)00884838068445(21);
(2) 781261 (01)00884838068438(21)
Serial Numbers:
Serial Number
77008
77000
77004
77001
77019
77010
77014
77007
77002
77016
77131
77070
77124
77144
77172
77074
77048
77177
77178
77181
77031
77047
77134
77050
77051
77060
77194
77034
77037
77038
77057
77072
77075
77078
77084
77085
77086
77092
77101
77110
77156
77157
77035
77111
77119
77167
77183
77185
77187
77188
77195
77196
77198
77199
77202
77052
77053
77054
77055
77056
77064
77065
77066
77067
77068
77069
77105
77125
77126
77135
77136
77137
77138
77139
77148
77141
77030
77032
77033
77036
77042
77043
77044
77049
77059
77061
77071
77083
77087
77088
77090
77091
77093
77097
77100
77106
77107
77112
77115
77118
77120
77121
77128
77129
77143
77151
77155
77158
77161
77162
77190
77191
77201
77166
77045
77063
77109
77117
77123
77081
77147
77113
77168
77169
77122
77154
77046
77094
77130
77062
77140
77039
77040
77058
77114
77127
77159
77160
77171
77179
77180
77182
77150
77041
77103
77203
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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 |
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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510(K) Database |
510(K)s with Product Code = LNH and Original Applicant = Philips Medical Systems Nederland BV
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