Class 2 Device Recall BrightView X

• Date Initiated by Firm: November 30, 2023
• Date Posted: January 05, 2024
• Recall Status: Open, Classified
• Recall Number: Z-0678-2024
• Recall Event ID: 93643
• 510(K)Number: K080927
• Product Classification: System, tomography, computed, emission - Product Code KPS
• Product: BrightView X, Gamma Camera, Product Code 882478
• Code Information: No UDI Serial numbers 11000072 11000116 11000007 11000010 11340001 11000027 11000032 4000570 11000041 11000092 11000113 11340003 11000044 11000006 11000033 11000025 11000105 11000016 11000003 11000018 11000065 11000047 11000066 11000101 11000107 11000090 11000029 11000056 11000026 11000046 11000051 11000078 11000114 11000067 11000050 11000084 11000068 11000052 11000057 11000055 11000070 11000088 11000023 11000061 11000060 11000095 11000094 11000102 11000054 11340004 11000091 11000083 11000098 11000063 11000013 11000015 11000062 11000035 11000081 11000009 11000017 11000110 11000004 11000008 11000005 11000020 11000011 11000014 11000012 11000019 11000022 11000031 11000024 11000034 11000036 11000028 11000030 11340002 11000042 11000037 11000080 11000079 11000039 11000040 11000069 11000038 11000045 11000086 11000049 11000043 11000048 11000059 11000058 11000097 11000096 11000073 11000074 11000071 11000064 11000075 11340005 11000077 11000076 11000089 11000087 11000085 11000106 11000100 11000093 11000104 11000099 11000103 11000115 11000112 11000109 11000117 11000108 11000118
• Recalling Firm/ Manufacturer: Philips North America; 222 Jacobs St; Cambridge MA 02141-2296
• For Additional Information Contact: Philips Customer Care Solutions Center; 800-722-9377
• Manufacturer Reason for Recall: While using Pre-Programmed Motion during an extrinsic quality assurance scan, a gap is created between the patient support and the detector, which may present a potential extremity entrapment hazard. Risk to patients may include fracture, body part loss of function/debilitation, muscle or ligament sprain or strain, laceration, crush injury, abrasion, or contusion.
• FDA Determined Cause: Device Design
• Action: On November 30, 2023, the firm notified customers of the issue through Urgent Medical Device Correction Letters. Users were instructed to monitor the patient during system movement when Pre-Programed Motion is in use and review the warning and caution guidance information provided with the recall notice, and which is also outlined in the Instructions for Use. Philips will contact you to schedule a time for a field service engineer to visit your site and install a technical solution to resolve this issue. 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).
• Quantity in Commerce: 59 US; 59 OUS
• Distribution: Domestic distribution nationwide. Foreign distribution worldwide.
• 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 = KPS and Original Applicant = PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.