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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-1837-2024 |
Recall Event ID |
94508 |
510(K)Number |
K193215
|
Product Classification |
System, nuclear magnetic resonance imaging - Product Code LNH
|
Product |
Achieva 1.5T Conversion- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): (1) 781283; (2) 781346 |
Code Information |
UDI-DI:
1. (01)00884838068469(21)
2. (01)00884838009806(21)
(1) Serial Numbers:
39011
39056
39084
39102
8989
10126
39098
39022
39079
39026
39097
39108
39082
39006
39013
39041
39081
39092
39096
39100
39010
39028
39032
39066
39086
39094
39095
39107
39001
39004
39064
39074
39007
39012
39029
39030
39034
39036
39038
39039
39040
39042
39054
39057
39058
39059
39062
39071
39075
39077
39080
39083
39088
39089
39091
39099
39105
39093
39053
39023
39008
39072
39073
39090
39104
39065
39052
39067
39085
39016
39025
39027
39060
(2)
18052
8361
8415
10015
75008
5243
8727
10172
10189
10545
18737
75002
75003
75004
75015
5547
8059
8767
8842
8883
8886
8897
8946
8981
8990
10060
18001
18710
75009
75092
75095
75099
75100
8276
10194
10512
8069
8312
8520
10006
10048
18588
75000
75001
75005
75049
75087
8289
8367
8714
8740
10539
75011
8351
8398
8782
75068
8756
75010
18505
75007
8371
8124
8467
8020
10219
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Recalling Firm/ Manufacturer |
Philips North America Llc 222 Jacobs St Cambridge MA 02141-2289
|
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 |
140 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 BV
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