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U.S. Department of Health and Human Services

Class 2 Device Recall Incisive CT

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  Class 2 Device Recall Incisive CT see related information
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.
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