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U.S. Department of Health and Human Services

Class 2 Device Recall Spectral CT on Rails

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 Class 2 Device Recall Spectral CT on Railssee related information
Date Initiated by FirmDecember 13, 2023
Date PostedFebruary 08, 2024
Recall Status1 Open3, Classified
Recall NumberZ-1054-2024
Recall Event ID 93798
510(K)NumberK212875 
Product Classification System, x-ray, tomography, computed - Product Code JAK
ProductSpectral CT on Rails: Software Version 5.1.0.X, model 728334.
Code Information UDI-DI: 00884838103627, serial number: 1005.
FEI Number 3017726341
Recalling Firm/
Manufacturer		 PHILIPS MEDICAL SYSTEMS
222 Jacobs St
Cambridge MA 02141-2289
Manufacturer Reason
for Recall		A software issue that can incorrectly label all captured images that may lead to misdiagnosis and subsequent incorrect treatment.
FDA Determined
Cause 2		Under Investigation by firm
ActionAn Urgent Medical Device Correction notice (2023-PD-CTAMI-017) dated December 13, 2023 was issued via Certified Mail. Philips Field Service Engineers will contact customers to schedule an onsite visit to install update software correcting the issue. Customers are asked to complete and return the response form and circulate the notice to all users of the device for awareness. Contact Philips Customer Care Solutions Center 1-800-722-9377 with questions.
Quantity in CommerceUS: 1
DistributionWorldwide - US Nationwide distribution in the states of AR, AZ, GA, HI, IN, KY, MA, MD, MN, NY, OH, PA, TX & WV; the countries of Australia, Austria, Belgium, China, Czech Republic, Denmark, Germany, Israel, Italy, Japan, Macao, Malaysia, Netherlands, Norway, Palestine, Panama, Portugal, Singapore, South Korea, Spain, Switzerland, Taiwan, Thailand & United Kingdom.
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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