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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-1850-2024 |
Recall Event ID |
94508 |
510(K)Number |
K213583 K193215
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Product Classification |
System, nuclear magnetic resonance imaging - Product Code LNH
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Product |
Ingenia Ambition S Model Number (REF): (1) 782139; (2) 782133; (3) 782108; (4) 781359
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Code Information |
UDI-DI:
(1) 782139 (01)00884838108639(21);
(2) 782133 N/A;
(3) 782108 (01)00884838098343(21);
(4) 781359 (01)00884838090057(21)
Serial Numbers:
Serial Number
48016
48053
48126
48003
48136
48285
48144
48020
48030
48124
48155
48191
48216
48218
48245
48300
48183
48186
48187
48222
48225
48234
48240
48241
48249
48269
48278
48284
48288
48293
48294
48299
48304
48313
48317
48326
48331
48051
48223
48207
48028
48031
48049
48050
48131
48134
48154
48160
48242
48254
48219
48000
48004
48005
48009
48019
48032
48132
48145
48224
48244
48040
48122
48039
48022
48152
48173
48012
48014
48036
48037
48044
48127
48151
48158
48174
48184
48043
48046
48047
48055
48128
48129
48153
48178
48180
48190
48192
48194
48226
48275
48181
48198
48199
48200
48023
48033
48045
48001
48038
48167
48185
48196
48236
48238
48239
48034
48276
48010
48170
48035
48172
48027
48248
48146
48147
48148
48163
48164
48165
48169
48182
48188
48271
48291
48297
48302
48303
48308
48309
48310
48329
48018
48283
48177
48011
48017
48056
48250
48272
48253
48268
48013
48015
48052
48112
48120
48130
48162
48166
48171
48179
48214
48217
48233
48237
48243
48252
48273
48274
48286
48287
48314
48026
48322
48133
48316
48558
48572
48566
48581
48592
48652
48800
48893
48544
48506
48520
48521
48534
48551
48712
48714
48715
48810
48813
48833
48883
48885
48538
48539
48602
48613
48650
48501
48502
48507
48514
48530
48540
48568
48569
48577
48579
48580
48590
48591
48614
48620
48629
48632
48638
48641
48503
48606
48660
48529
48609
48622
48541
48549
48616
48504
48508
48513
48524
48536
48537
48555
48560
48571
48573
48585
48593
48594
48597
48600
48522
48561
48564
48668
48726
48519
48532
48533
48505
48510
48567
48604
48515
48584
48512
48582
48647
48850
48610
48615
48500
48523
48535
48546
48552
48554
48562
48575
48578
48586
48637
48645
48648
48656
48525
48526
27500
27502
27504
27505
27506
27507
27508
27509
27511
27512
27514
27515
27516
27517
27518
27519
27520
27522
27523
27524
27525
27526
27527
27528
27529
27530
27531
27532
27533
27535
27536
27539
27541
27542
27543
27544
29021
29000
29010
29011
29012
29014
29017
29018
29025
29003
29006
29009
29015
29023
29013
29027
29005
29019
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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 |
328 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. 510(K)s with Product Code = LNH and Original Applicant = Philips Medical Systems Nederland BV
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