Class 2 Device Recall BrightView X

• Date Initiated by Firm: June 10, 2019
• Create Date: July 22, 2019
• Recall Status: Terminated on July 24, 2020
• Recall Number: Z-2010-2019
• Recall Event ID: 83201
• 510(K)Number: K080927
• Product Classification: System, tomography, computed, emission - Product Code KPS
• Product: BrightView X , Model Number 882478
• Code Information: Serial Numbers: 11000044 11000006 11000033 11000025 11000105 11000016 11000072 11000116 11000101 11000065 11000047 11000018 11000003 11000066 11000078 11000046 11000051 11000114 11000026 11000032 11340001 11000007 11000010 11000027 11000084 11000088 11000057 11000052 11000055 11000068 11000050 11000067 11000070 11000095 11000023 11000102 11000060 11000061 11000094 11000054 11340004 11000091 11000098 11000083 11000063 11000013 11000015 11000062 11000081 11000035 11000009 11000110 11000017 11000090 11000107 11340003 11000056 11000029 11000092 11000041 11000042 11000020 11000109 11000008 11000011 11000039 11000087 11000100 11000093 11000079 11000080 11000074 11000005 11000071 11000043 11000049 11000089 11000030 11000037 11000014 11000104 11000038 11000106 11340002 11000085 11000108 11000040 11000059 11000112 11000045 11000076 11000028 11000113 11000117 11000103 11000069 11000012 11000075 11000004 11000096 11000097 11000048 11000058 11000118 11000086 11000077 11000036 11340005 11000064 11000022 11000031 11000073 11000024 11000019 11000099 11000034 11000115
• Recalling Firm/ Manufacturer: Philips Medical Systems (Cleveland) Inc; 595 Miner Rd; Cleveland OH 44143-2131
• For Additional Information Contact: Holly Wright Lee; 440-483-7600
• Manufacturer Reason for Recall: An issue with the handcontroller may result in either spontaneous uncommanded motions or continued motion after the buttons were released.
• FDA Determined Cause: Under Investigation by firm
• Action: Urgent Field Safety Notice Medical Device Correction letters dated 6/4/19 were sent to customers. Discontinue Use of the BrightView Handcontroller. Remove the handcontroller from the charging station and store in a secure location inaccessible by technicians, at least 20 meters (65 feet) away from the system and outside the imaging room. If 20 meters (65 feet) is not possible, then store the handcontroller in an area that is shielded, such as a hot lab. Do not dispose of the hand controller, as it will be needed once a solution is identified. Instead of the physical handcontroller, use the virtual handcontroller located on the touchscreen monitor attached to the gantry as shown in Figure 3. Philips Healthcare is distributing this FSN to all affected customers/users and will deploy a technical solution addressing the issue upon completion of the investigation. If you need any further information or support concerning this issue, please contact your local Philips representative: For SUPPORT in North America and Canada, contact the Customer Care Solutions Center (1-800-722-9377, follow the prompts).
• Quantity in Commerce: 117
• Distribution: Worldwide Distribution - US Nationwide
• 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 = KPS and Original Applicant = PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.