Recall record at a glance
| Official record | Z-0593-2017 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class III |
| FDA record status | Terminated |
| Recalling firm | Philips Medical Systems (Cleveland) Inc. |
| Report date | Nov 23, 2016 |
| Recall initiation date | Oct 13, 2016 |
| Quantity | 67 |
| Location | Cleveland, OH, United States |
Official product description
Brilliance iCT Computed Tomography X-ray system, Model 728306
Why the product was recalled
The product label does not include the correct current rating.
Distribution information
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.
How to read the classification
FDA Class III generally covers situations in which use of or exposure to the product is not likely to cause adverse health consequences. The classification displayed here is taken from the FDA enforcement record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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