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U.S. Department of Health and Human Services

Class 2 Device Recall Spectral CT

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  Class 2 Device Recall Spectral CT see related information
Date Initiated by Firm March 29, 2024
Date Posted May 02, 2024
Recall Status1 Open3, Classified
Recall Number Z-1756-2024
Recall Event ID 94352
510(K)Number K203020  
Product Classification System, x-ray, tomography, computed - Product Code JAK
Product The Oncology Essentials Package of the Spectral CT imaging system.
Code Information Model No. 728333; UDI: (01)00884838101111(21); Serial No. 10069, 10084, 10169, 10137, 10163, 10196, 10181, 10199, 10210, 10206, 10202, 10139.
Recalling Firm/
Manufacturer		 Philips North America Llc
222 Jacobs St
Cambridge MA 02141-2289
For Additional Information Contact Philips Customer Care Solutions Center
1-800-722-9377
Manufacturer Reason
for Recall		 Potential for third party oncology marking laser to be reflected off the gantry cover surface, which can potentially lead to misdiagnosis and subsequent incorrect treatment.
FDA Determined
Cause 2		 Under Investigation by firm
Action An URGENT Medical Device Correction Letter, dated 3/27/24, was mailed to consignees to notify them of this recall. Consignees are instructed to identify if a third-party laser was installed on their system and if the laser line is reflected, duplicated, or thickened. If a third-party laser is installed, before treatment of a patient, reposition or re-image as necessary to verify proper placement of the localization laser marks. Systems may continue to be used in accordance with the intended use and provided use recommendations. Consignees are to complete and return the provided response form by email to CTNM.QARA@philips.com. The provided recall notification is to be disseminated to all users of affected systems. Philips will contact consignees to schedule a time for a Field Service Engineer to visit and install hardware to resolve the issue. Questions are to be directed to the Customer Care Solutions Center at 1-800-722-9377 from 8:00 AM to 8:00 PM, Monday through Friday.
Quantity in Commerce 12 units
Distribution Worldwide distribution - US Nationwide in the states of AZ, HI, MN, VT, WV and the countries of China, Macao, New Zealand, Portugal, Switzerland.
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 Medical Systems Nederland B.V.
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