Brilliance ICT SP Computed Tomography X-ray system, Model 728311
Reported: November 23, 2016 Initiated: October 13, 2016 #Z-0594-2017
Product Description
Brilliance ICT SP Computed Tomography X-ray system, Model 728311
Reason for Recall
The product label does not include the correct current rating.
Details
- Recalling Firm
- Philips Medical Systems (Cleveland) Inc
- Units Affected
- 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.
- Location
- Cleveland, OH
Frequently Asked Questions
What product was recalled? ▼
Brilliance ICT SP Computed Tomography X-ray system, Model 728311. Recalled by Philips Medical Systems (Cleveland) Inc. Units affected: 3.
Why was this product recalled? ▼
The product label does not include the correct current rating.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 23, 2016. Severity: Low. Recall number: Z-0594-2017.
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