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U.S. Department of Health and Human Services

Class 2 Device Recall Phillips

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  Class 2 Device Recall Phillips see related information
Date Initiated by Firm April 13, 2021
Create Date June 02, 2021
Recall Status1 Terminated 3 on September 23, 2022
Recall Number Z-1774-2021
Recall Event ID 87872
510(K)Number K060937  
Product Classification System, x-ray, tomography, computed - Product Code JAK
Product BRILLIANCE VOLUME system - A Computed Tomography X-Ray System intended to produce images of the head and body.

Model Number: 728306
Code Information Serial Numbers: 100100, 100434  
Recalling Firm/
Manufacturer		 Philips North America Llc
222 Jacobs St
Cambridge MA 02141-2289
Manufacturer Reason
for Recall		 Cooling Unit (CLU) expelled out of a CT gantry of an iCT system may result in injury
FDA Determined
Cause 2		 Under Investigation by firm
Action Philips Regional Service Manager spoke to Customer on 13 April 2021, and advised them to stop use of the product until repair could be completed and followed communication by email. On 14-Apr-2021 component was replaced and system returned to service.
Quantity in Commerce 2 units (1 US and 1 OUS)
Distribution Worldwide distribution - US Nationwide distribution in the state of NV and the country of Japan.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JAK and Original Applicant = PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
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