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U.S. Department of Health and Human Services

Class 2 Device Recall BrightView X upgrade to XCT

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  Class 2 Device Recall BrightView X upgrade to XCT see related information
Date Initiated by Firm December 23, 2016
Create Date February 10, 2017
Recall Status1 Terminated 3 on July 02, 2018
Recall Number Z-1187-2017
Recall Event ID 76183
510(K)Number K080927  
Product Classification System, tomography, computed, emission - Product Code KPS
Product BrightView X upgraded to XCT 882454
Code Information Two systems were converted into the BrightView XCT and are included in the codes for prouct 1.
Recalling Firm/
Manufacturer		 Philips Medical Systems (Cleveland) Inc
595 Miner Rd
Cleveland OH 44143-2131
For Additional Information Contact Ms. Holly Wright Lee
440-483-2950
Manufacturer Reason
for Recall		 The intended use listed in the English and localized language IFUs for BrightView XCT systems did not match the intended use documented in the 510K submission.
FDA Determined
Cause 2		 Under Investigation by firm
Action All customers were notified via certified mail with return receipt. International customers were notivied via Philips employees. A field change order was initiated. Non-responders will be followed up on. Lastly, effectivenss checks will be conducted.
Distribution Products were distributed in the following states: AZ, CA, CO, DC, DE, FL, GA, IL, LA, MA, MD, MN, MO, MS, MT, NC, NJ, NY, OH, OK, OR, PA, PR, TX, VT, WA, & WI. Product was distributed internationally to the following countries: Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, France, Gabon, Germany, Greece, India, Indonesia, Ireland, Israel, Italy, Japan, Korea, Lebanon, Lithuania, Malaysia, Netherlands, New Zealand, Norway, Panama, Poland, Portugal, Russian Federation, Saudia Arabia, Slovakia, South AFrica, Apain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, and Viet Nam.
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.
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