Recall record at a glance
| Official record | Z-0177-2016 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Philips Medical Systems (Cleveland) Inc. |
| Report date | Nov 4, 2015 |
| Recall initiation date | Sep 14, 2015 |
| Quantity | 268 units total |
| Location | Cleveland, OH, United States |
Official product description
Brilliance Big Bore (Oncology & Radiology) Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body.
Why the product was recalled
The firm discovered Ring/Dot artifact due to X-ray measurement error.
Distribution information
Worldwide Distribution-US (nationwide) including DC and the states of AL, AR, AS, AZ, CA, CO, CT, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NH, NJ, NV, NY, OH, OK, OR, SC, TN, TX, UT, VA, VT, WI & WV, and the countries of Albania, Algeria, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, China, Czech Republic, Denmark, Ecuador, Egypt, Ethiopia, Finland, France, Germany, Hong Kong, India, Indonesia, Iran, Iraq, Italy, Japan, Jordan, Kazakhstan, Latvia, Lebanon, Libya, Lithuania, Malaysia, Mexico, Mongolia, Myanmar, Netherlands, Nigeria, Norway, Oman, Panama, Philippines, Poland, Portugal, Romania, Russia, Rwanda, Samoa, Saudi Arabia, Singapore, South Korea, Spain, State of Palestine, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan & Viet Nam.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA 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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