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U.S. Department of Health and Human Services

Class 2 Device Recall Philips Incisive CT

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 Class 2 Device Recall Philips Incisive CTsee related information
Date Initiated by FirmApril 25, 2023
Date PostedJuly 28, 2023
Recall Status1 Open3, Classified
Recall NumberZ-2261-2023
Recall Event ID 92202
510(K)NumberK180015 
Product Classification System, x-ray, tomography, computed - Product Code JAK
ProductIncisive CT Plus-Computed Tomography X-Ray System Model: 728149
Code Information UDI-DI: (01)00884838103474(21) Serial Numbers: 530408 530437 530474 530320 530332 530430
Recalling Firm/
Manufacturer
Philips North America
222 Jacobs St
Cambridge MA 02141-2296
For Additional Information ContactPhilips Customer Care Solutions Center
800-722-9377
Manufacturer Reason
for Recall
Metal mounting box on the rotating scanner on rotor (heat exchanger box) located within the Incisive CT system may become expelled and make contact with other components and cause injury to user or if detached a loud noise will be emitted and the system will shut down
FDA Determined
Cause 2
Under Investigation by firm
ActionPhiips issued Urgent Medical Device Correction Letters mailed to US consignees via Certified United States Postal Service (USPS) with delivery confirmation on 4/25/23 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 FCO72800798). If you need additional information or support concerning this issue, please contact the Customer Care Solutions Center (1-800-722-9377).
Quantity in Commerce6 units OUS
DistributionNationwide Foreign: China Algeria Argentina Australia Austria Azerbaijan Bahrain Bangladesh Belarus Belgium Bolivia Brazil Bulgaria Canada Chile China Colombia Czech Republic Ecuador Egypt France Germany Greece India Indonesia Iran Iraq Israel Italy Japan Jordan Korea, Republic of Kosovo Latvia Macedonia Mexico Moldova Netherlands Nigeria Pakistan Panama Philippines Poland Romania Russian Federation Saint Lucia Saint Pierre and Miquelon Saudi Arabia Serbia Slovakia Spain Sweden Taiwan Thailand Tunisia Turkey Turkmenistan United Kingdom Uzbekistan Viet Nam
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = JAK
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