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U.S. Department of Health and Human Services

Class 2 Device Recall BrightView and BrightView X

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  Class 2 Device Recall BrightView and BrightView X see related information
Date Initiated by Firm December 15, 2017
Date Posted February 03, 2018
Recall Status1 Terminated 3 on April 10, 2020
Recall Number Z-0510-2018
Recall Event ID 79088
510(K)Number K062298  
Product Classification System, tomography, computed, emission - Product Code KPS
Product BrightView X, Model #882478

Product Usage:
BrightView and BrightView X are gamma cameras designed for single or dual detector nuclear imaging accommodating a broad range of Emission Computed Tomography (ECT) studies. The cameras can be used to perform planar static, dynamic, gated, and total body studies, as well as circular-orbit and noncircular orbit SPECT studies, gated SPECT (circular and noncircular)studies, computer-programmed protocol strings, and reference scans (dual detectors only).
Code Information BrightView X, Model # 882478 Serial Numbers: 11000044 11000006 11000033 11000025 11000105 11000016 11000072 11000116 11000003 11000018 11000066 11000047 11000101 11000065 11000114 11000078 11000051 11000046 11000026 11000007 11000010 11000027 11000032 11340001 11000055 11000070 11000084 11000088 11000068 11000052 11000057 11000050 11000067 11000102 11000061 11000095 11000023 11000094 11000060 11000054 11340004 11000083 11000091 11000098 4000570 11000063 11000062 11000013 11000015 11000035 11000081 11000009 11000017 11000110 11000090 11000107 11340003 11000056 11000029 11000100 11000019 11000034 11000020 11000112 11000086 11000045 11000092 11000037 11000106 11000038 11000059 11000064 11000039 11000087 11000004 11000058 11000030 11340005 11000113 11000117 11000011 11000118 11000074 11000075 11000036 11000104 11000103 11000071 11340002 11000089 11000012 11000041 11000042 11000043 11000049 11000014 11000099 11000022 11000031 11000005 11000028 11000073 11000040 11000077 11000008 11000048 11000093 11000096 11000097 11000069 11000079 11000080 11000024 11000076 11000085 11000108 11000109 11000115 
Recalling Firm/
Manufacturer		 Philips Medical Systems (Cleveland) Inc
595 Miner Rd
Cleveland OH 44143-2131
For Additional Information Contact Holly Wright Lee
440-483-2950
Manufacturer Reason
for Recall		 During collimator exchange, the alignment of the collimator cart and detectors may cause a collimator exchange fail, and a collimator may drop to the floor beside the collimator cart. The collimator may be partially supported by the cart (e.g. leaning against the cart), or it may fall/slide all the way to the floor.
FDA Determined
Cause 2		 Under Investigation by firm
Action Philips sent an Urgent Field Safety Notice letter dated December 15, 2017 to affected customers. The letter identified the affected product, problem and actions to be taken. For questions contact your local Philips representative.
Quantity in Commerce 1387 in total
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 = ADAC LABORATORIES
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