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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-1862-2024 |
Recall Event ID |
94508 |
Product Classification |
System, nuclear magnetic resonance imaging - Product Code LNH
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Product |
SmartPath to dStream for XR and 3.0T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device.
Model Number (REF): (1) 782129; (2) 782113; (3) 781270
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Code Information |
UDI-DI:
(1) 782129 (01)00884838105805(21);
(2) 782113 (01)00884838098909(21);
(3) 781270 (01)00884838095083(21)
Serial Numbers:
Serial Number
17536
17546
17212
17508
23011
35056
17434
17302
17429
24108
17006
17378
17386
17533
17590
35052
17204
17264
17292
17339
17398
17415
17416
17436
17440
17447
17544
23030
24055
35087
17473
17283
17247
17265
17268
17286
17353
17367
17389
17425
17509
17517
17572
17580
24022
24036
24098
35020
35078
23002
24018
17514
17524
23026
24087
24095
17260
17222
17242
17245
17250
17269
17299
17308
17309
17342
17357
17388
17399
17464
17468
17493
17499
17556
17559
17564
17565
17569
17589
17594
24006
24012
24023
24047
24109
24110
24111
24124
24134
24143
35027
35046
35048
38015
17305
24117
17266
17471
17428
38131
17194
17246
23036
17610
17550
24145
34250
17237
17352
17321
17344
17495
17570
17615
24020
24090
17274
35047
17326
17466
24075
17172
17360
17369
17490
24007
24025
38199
17356
17406
17206
17239
17240
17284
17375
17459
17516
23033
24058
24076
35019
35032
35040
17366
17215
17376
17449
17455
17470
34059
34262
38106
17252
34172
38070
38142
17439
38350
74040
17504
34072
35041
38105
17271
17346
24021
24077
24093
24146
34117
34127
34128
34129
34131
34153
34202
35059
38094
38290
38311
17258
38310
34212
38042
38281
17560
38166
38183
24039
34110
38117
17521
38010
38219
17307
38075
38222
34055
38195
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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 |
200 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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