Date Initiated by Firm |
April 15, 2024 |
Date Posted |
May 20, 2024 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-1872-2024 |
Recall Event ID |
94536 |
510(K)Number |
K212441
|
Product Classification |
System, x-ray, tomography, computed - Product Code JAK
|
Product |
Incisive CT - Computed Tomography X-Ray System intended to produce cross-sectional images of the body.
Model Number: 728144
|
Code Information |
UDI-DI: Unique Device Identifier Rule: {01)00884838105508(21) + Serial number
Serial Numbers-Applied to FCO72800820:
34002
34006
34007
34018
34019
34023
34025
34026
34031
34032
34033
34038
34040
34041
34042
34047
34049
34050
34051
34052
34053
34054
34055
34056
34057
34058
34059
34060
34064
34066
34067
34068
34071
34072
34073
34074
34075
34077
34078
34079
34080
34081
34082
34083
34085
34086
34088
34089
34090
34091
34092
34093
34095
34097
34100
34101
34102
34103
34105
34106
34111
34112
34116
34117
34119
34122
34126
34128
34130
34131
34132
34133
34134
34135
34137
34146
34149
34150
34152
34153
34160
34162
34163
34164
34165
34168
34169
34174
34175
34179
34187
34190
34191
34193
34195
34198
34201
34203
34206
34208
34218
34221
34223
34226
34229
34235
34240
34244
34251
34257
34259
34260
34263
34264
34265
34267
34270
34276
34277
34279
34280
34281
34282
34285
34289
34294
34295
34301
34315
34324
34325
34326
34327
34335
34337
34338
34344
34348
34350
34351
34358
34367
34368
34374
34384
34385
550243
550503
Serial Numbers -Applied to FCO72800820:
34337 34350 34341 550503 34351 34358 34367 34368 34374 34384 34385 |
Recalling Firm/ Manufacturer |
Philips North America Llc 222 Jacobs St Cambridge MA 02141-2289
|
For Additional Information Contact |
Philips Customer Care Solutions Center 800-722-9377
|
Manufacturer Reason for Recall |
Metal mounting box on the rotating scanner on rotor (heat change box) located within the Incisive CT system, may become compromised, resulting in potential contact with other gantry components located within the Incisive CT system during rotation. Resulting in a fragment of a damaged component expelled at a low velocity
|
FDA Determined Cause 2 |
Under Investigation by firm |
Action |
Philips issued URGENT Medical Device Correction Letter on 4/15/24 to US consignees.
[International global markets were notified of the issue and instructed to distribute the
FSN to affected consignees in accordance with local requirements].
Letter states reason for recall, health risk and action to take:
" Please continue to use your system in accordance with its intended use. If you need to
remain in the room for the duration of a scan, Philips recommends using protective
eyewear.
" Circulate this Urgent Medical Device Correction Letter to all users of this device so that they
are aware of the issue. Please retain this letter with your system(s) until a solution is
installed on your system; ensure the letter is in a place likely to be seen/viewed.
" Place this URGENT Medical Device Correction Letter with your system documentation.
" Please complete and return the attached response form to Philips promptly and no later than 30 days from receipt. Completing this form confirms receipt of the Urgent Medical Device Correction Letter, understanding of the issue, and required actions to be taken .
Philips will contact you to schedule a time for a Field Service Engineer (FSE) to visit your site and install a solution to address the issue (reference FCO72800819 and FCO72800820).
If you need additional information or support concerning this issue, please contact the Customer Care Solutions Center (1-800-722-9377). |
Quantity in Commerce |
155 units |
Distribution |
Worldwide - US Nationwide distribution. |
Total Product Life Cycle |
TPLC Device Report
|
|
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.
|
510(K) Database |
510(K)s with Product Code = JAK and Original Applicant = Philips Healthcare (Suzhou) Co., Ltd.
|