Recall record at a glance
| Official record | Z-0705-2017 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Philips Medical Systems (Cleveland) Inc. |
| Report date | Dec 14, 2016 |
| Recall initiation date | Nov 14, 2016 |
| Quantity | 24 |
| Location | Cleveland, OH, United States |
Official product description
IQon Spectral CT is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.
Why the product was recalled
A software defect is causing issues with the IQon Spectral CT and Philips Spectral CT Applications while filming, saving and annotating images
Distribution information
Software was distributed in the following states: AR, IN, LA, MA, MN, OR and TN. Softward was also shipped to the following countries: Belgium, Denmark, France, Germany, Japan, Korea, Switzerland and United Kingdom.
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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