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U.S. Department of Health and Human Services

Class 2 Device Recall BrightView, BrightView X, BrightView XCT

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 Class 2 Device Recall BrightView, BrightView X, BrightView XCTsee related information
Date Initiated by FirmNovember 04, 2014
Date PostedDecember 01, 2014
Recall Status1 Terminated 3 on July 02, 2018
Recall NumberZ-0450-2015
Recall Event ID 69783
510(K)NumberK062298 K080927 
Product Classification System, tomography, computed, emission - Product Code KPS
ProductBrightView product code: 882478 BrightView X product code: 882480 BrightView XCT product code: 882482 and 882454
Code Information BrightView: 11000022, 11000028, 11000050, 1000067, 11000070, 11000073, 1000079, 11000080, 11000084, 11000088, and 11000109.  BrightView X:4000007, 4000034, 4000045, 4000049, 4000050, 4000052, 4000055, 4000057, 4000062, 4000091, 4000110, 4000119, 4000145, 4000178, 4000186, 4000192, 4000203, 4000215, 4000221, 4000234, 4000267, 4000268, 4000273, 4000315, 4000332, 4000335, 4000337, 4000340, 4000343, 4000349, 4000351, 4000359, 4000391, 4000404, 4000436, 4000447, 4000493, 4000497, 4000500, 4000517, 4000595, 4000599, 4000605, 4000609, 4000616, 4000617, 4000622, 4000648, 4000653, and 4000675.  BrightView XCT: 6000018, 6000024, 6000025, 6000029, 6000059, 6000072, 6000074, 6000096, 6000097, 6000106, 6000155, 6000170, 6000179, 6000217, 6000255, 6000259, 6000272, 6000328, 6000342, 6000357, 6000388, 6000405, 6000412, 6340011, and 11000082.
FEI Number 1525965
Recalling Firm/
Manufacturer		 Philips Medical Systems (Cleveland) Inc
595 Miner Rd
Cleveland OH 44143-2131
For Additional Information Contact
440-483-7600
Manufacturer Reason
for Recall		Software issues
FDA Determined
Cause 2		Software design
ActionPhilips Healthcare sent an URGENT - Field Safety Notice Medical Device Correction letter dated November 4, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. This Field Safety Notice 88200485 is intended to inform you about: " what the issues are and under what circumstances they can occur " the actions that should be taken by the customer / user in order to prevent risks for patients or users " the actions planned by Philips to correct these issues. If you need any further information or support concerning these issues, please contact your local Philips representative: For North America contact the Customer Care Solutions Center (1-800-722-9377: follow the prompts). Philips apologizes for any inconveniences caused by this problem.
Quantity in Commerce85
DistributionWorldwide Distribution - USA including the states of AR, CA, FL, GA, ID, LA, ME, MI, MN, MO, MS, NJ, NY, OH, OK, PA, and TX. Government Facilities: AR, FL, MN, OH, and OK. and the countries of: Canada, China, Denmark, Germany, Italy, South Korea, Spain, Sweden, Switzerland, Taiwan, and United Kingdom.
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 = KPS
510(K)s with Product Code = KPS
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