| Class 3 Device Recall IQon Spectral CT Computed Tomography Xray system | |
Date Initiated by Firm | October 13, 2016 |
Create Date | November 16, 2016 |
Recall Status1 |
Terminated 3 on June 29, 2018 |
Recall Number | Z-0598-2017 |
Recall Event ID |
75516 |
510(K)Number | K133674 |
Product Classification |
System, x-ray, tomography, computed - Product Code JAK
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Product | IQon Spectral CT Computed Tomography X-ray system, Model 728332 |
Code Information |
860005, 860006, 860010 |
Recalling Firm/ Manufacturer |
Philips Medical Systems (Cleveland) Inc 595 Miner Rd Cleveland OH 44143-2131
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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 | 3 |
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 |
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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.
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510(K) Database | 510(K)s with Product Code = JAK
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