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U.S. Department of Health and Human Services

Class 3 Device Recall Ingenuity CT Computed Tomography Xray system

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  Class 3 Device Recall Ingenuity CT Computed Tomography Xray system see related information
Date Initiated by Firm October 13, 2016
Create Date November 16, 2016
Recall Status1 Terminated 3 on June 29, 2018
Recall Number Z-0595-2017
Recall Event ID 75516
510(K)Number K160743  
Product Classification System, x-ray, tomography, computed - Product Code JAK
Product Ingenuity CT Computed Tomography X-ray system, Model 728326
Code Information 30003, 30004, 30008, 30014, 30033, 30039, 30040, 30041, 30042, 30043, 30044, 300037, 300066, 300097, 300151, 300156, 300157, 300203, 300204, 300205, 300206, 300207, 300208, 300209, 300210, 300211, 300212
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		 The product label does not include the correct current rating.
FDA Determined
Cause 2		 Labeling Change Control
Action The firm will send a customer letter via certified mail and will have the receipts returned for tracking purposes. Also, a Field Service Engineer will implement the Field Change Order on affected systems to resolve the issue. Implementation of the Field Change Order will be monitored.
Quantity in Commerce 27
Distribution Worldwide distribution. The products were shipped to the following states: AL, AZ, CO, GA, IN, KY, LA, MA, MN, NY, OH, PA, SC, TX, and UT. There are five (5) government accounts for this recall: DEPARTMENT OF VETERANS AF, VETERANS WAY AND LAMONT ST, Mountain Home, TN 37684; US ARMY EVANS COMMUNITY H, 1650 Cochrane Cir, Colorado Springs, CO 80913; US VETERANS ADMINISTRATION, 3710 SW US VETERANS HOSPITAL, PORTLAND, OR 97239; VA MEDICAL CENTER, 4100 W 3RD ST, DAYTON, OH 45428; VAMC - PHILADELPHIA, UNIVERSITY & WOODLAND AVE, PHILADELPHIA, PA 19104. There are five (5) Canadian accounts for this recall: FIVE HILLS HEALTH REGION, 55 DIEFENBAKER DR, MOOSE JAW, SASKATCHEWAN S6J 0C2; INSTITUT UNIV CARDIOLOGIE, 2725 CH STE FOY, SAINTE FOY, QUEBEC G1V 4G5; LAKERIDGE HEALTH, 1 HOSPITAL CRT, OSHAWA, ONTARIO L1G 2B9; LAKERIDGE HEALTH BOWMANVI, 47 LIBERTY ST S, BOWMANVILLE, ONTARIO L1C 2N4; MCGILL UNIVERSITY HEALTH, 1051 BOUL D¿CARIE, MONTR¿AL, QUEBEC H4A 0A5. There were zero (0) Mexican accounts for this recall. The recalled products were shipped to the following countries: Argentina, Australia, Belgium, China, Egypt, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Japan, Republic of Korea, Lebanon, Netherlands, New Zealand, Norway, Russian Federation, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, and United Kingdom.
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 = JAK and Original Applicant = Philips Medical Systems (Cleveland), Inc.
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