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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-1854-2024 |
Recall Event ID |
94508 |
510(K)Number |
K212673
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Product Classification |
System, nuclear magnetic resonance imaging - Product Code LNH
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Product |
MR 5300- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): (1) 782152 (2) 782110 |
Code Information |
UDI-DI:
(1) 782152 N/A
(2) 782110 (01)00884838099364(21)
Serial Numbers:
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
Serial Number:
30199
30200
30201
30062
30191
30240
30241
30242
30305
30315
30125
30088
30113
30222
30252
30268
30028
30038
30058
30069
30081
30095
30100
30117
30118
30138
30164
30167
30168
30169
30170
30192
30197
30207
30209
30217
30228
30246
30248
30249
30256
30262
30267
30281
30284
30289
30297
30298
30306
30307
30312
30314
30210
30219
30245
30254
30276
30029
30043
30052
30061
30083
30101
30107
30114
30115
30116
30119
30120
30122
30130
30137
30140
30153
30154
30158
30159
30160
30163
30173
30174
30177
30178
30179
30196
30203
30251
30253
30259
30265
30266
30277
30279
30280
30282
30285
30291
30293
30104
30105
30216
30244
30290
30308
30316
30070
30208
30102
30112
30133
30206
30214
30224
30238
30261
30264
30274
30295
30303
30051
30084
30149
30215
30227
30232
30233
30234
30235
30035
30055
30143
30148
30272
30288
30294
8281
30304
30142
30218
30109
30131
30063
30091
30094
30202
30059
30099
30175
30176
30198
30237
30263
30269
30270
30302
30309
8002
8143
8122
8855
8404
30053
30075
30145
30064
30065
30123
30171
30085
30190
30226
30230
30231
30213
30135
30152
30155
30180
30181
30182
30183
30184
30185
30186
30187
30189
30220
30221
30223
30243
30250
30283
30310
30311
30017
30030
30047
30098
10193
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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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510(K) Database |
510(K)s with Product Code = LNH and Original Applicant = Philips Medical Systems Nederland B.V.
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