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U.S. Department of Health and Human Services

Class 2 Device Recall Brilliance iCT

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 Class 2 Device Recall Brilliance iCTsee related information
Date Initiated by FirmApril 06, 2020
Date PostedMay 06, 2020
Recall Status1 Terminated 3 on September 16, 2022
Recall NumberZ-1921-2020
Recall Event ID 85513
510(K)NumberK060937 
Product Classification System, x-ray, tomography, computed - Product Code JAK
ProductPhilips Brilliance iCT Computed Tomography X-Ray System; Model # 728306; UDI #s (01)00884838059474(21)100783, (01)00884838059474(21)100848
Code Information Serial #s 100193, 100408, 100457, 100783, 100356, 100113, 100380, 100318, 100848, 100112, 100742, 100447, 100685, 100375, 100449, 100659, 100158, 100398  Additional serial number as of 5/22/20: 100117 
Recalling Firm/
Manufacturer
Philips North America, LLC
3000 Minuteman Rd
Andover MA 01810-1032
For Additional Information ContactMs. Holly Wright Lee
440-869-4807
Manufacturer Reason
for Recall
The bolt affixing the cooling unit to the rotor was not tightened to specification on the Philips Brilliance iCT systems.
FDA Determined
Cause 2
Process control
ActionPhilips sent a Medical Device Correction-Urgent Field Safety Notice dated April 6, 2020 to all affected customers. The firm instructed customers to review the information with all members of the staff who need to be aware of the contents of the notice and to maintain a copy with the equipment in the Instructions for Use. Customers were directed to complete and return the form stating that they received, read, and understood the contents of the letter and have taken appropriate actions. URGENT - Field Safety Notice Medical Device Correction letter dated 5/20/20 was sent to customers informing them of two additional affected systems. There is no action required by the customer. Testing and engineering analysis demonstrate that the under-torqued bolts do not pose any immediate safety risk as the mechanical connection between the cooling unit and the rotor continues to meet applicable safety standards. The affected systems may continue to be used according to the IFU. Philips is distributing this FSN to all affected customers/users and will correct the issue via Field Change Order FCO 72800725. Urgent Field Safety Notice Medical Device Correction dated 5/20/20 was distributed to notify additional systems not previously included in the original notification. There is no action required by the customer. Testing and engineering analysis demonstrate that the under-torqued bolts do not pose any immediate safety risk as the mechanical connection between the cooling unit and the rotor continues to meet applicable safety standards. The affected systems may continue to be used according to the IFU. Philips is distributing this FSN to all affected customers/users and will correct the issue via Field Change Order FCO 72800725. If you need any further information or support concerning this issue, please contact your local Philips representative: For North America, contact the Customer Care Solutions Center (1-800-722-9377, follow the prompts).
Quantity in Commerce19
DistributionWorldwide distribution including one unit distributed to Iowa.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = JAK
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