Recall record at a glance
| Official record | Z-1813-2016 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Volcano Corporation |
| Report date | Jun 1, 2016 |
| Recall initiation date | Apr 25, 2016 |
| Quantity | 5875 (2685 in US; 3190 ROW) |
| Location | Rancho Cordova, CA, United States |
Official product description
Volcano s5, s5i, CORE and CORE Mobile systems with software version 3.4 and v3.4 software kits. Cardiology: The Volcano Universal (Core /Core Mobile), S5iz Platform Imaging System is used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature.
Why the product was recalled
Volcano has become aware of an incompatibility issue between Impacted Systems and hospital network scans. In specific circumstances, an impacted System will encounter unexpected data from the hospital network and be forced to reboot
Distribution information
Worldwide Distribution: US (nationwide) and countries of: Japan, South Africa, Germany, Sweden, Belgium, France, Italy, Spain, India, Russian Federation, Hungary, Turkey, Poland, Portugal, Costa Rica, Finland, Great Britain, Croatia, India, Chile, Thailand, Mauritius, Iraq, Denmark, Norway, Ireland, Netherlands, Bulgaria, Czech Republic, Luxembourg, UAE, Austria, Poland, Pakistan, Sri Lanka, Kazakhstan, Slovakia, Saudi Arabia, Unite Arab Emirates, Egypt., Jordan, Kuwait, Lebanon, Bulgaria, Romania, Latvia, Lithuania, Bosnia and Herzegovina, Greece, Malta, Cyprus, Romania, Tunisia, Kenya, Algeria, Israel, Jordan, Hong Kong, Republic of Korea, Malaysia, New Zealand, Venezuela, Brazil, Philippines, Australia, Taiwan, Peru, Singapore, Panama, Mexico, Argentina, Costa Rica, Dominican Republic, China, and Paraguay,
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.
FDA source limitation: openFDA enforcement reports are a reference dataset, not a live public-alert or recall-lifecycle service. FDA notes that enforcement-report status may not be updated after classification. Confirm current actions with the FDA, recalling firm or appropriate healthcare professional when relevant.