FDA Device recall Z-1813-2016
Volcano s5, s5i, CORE and CORE Mobile systems with software version 3.4 and v3.4 software kits
- FDA Device
- Class II
- terminated
- Published 2016-06-01
On 2016-06-01 the FDA classified a Class II recall of Volcano s5, s5i, CORE and CORE Mobile systems with software version 3.4 and v3.4 software kits by Volcano, citing volcano has become aware of an incompatibility issue between Impacted Systems and hospital network scans. In specific circumstances, an impacted System will encounter unexpected d….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1813-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-04-25 |
| Published | 2016-06-01 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Volcano |
| Distribution | US |
Product
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.
Reason
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
Identifiers
| code_info | Systems with software version 3.2.x, 3.3,and 3.4 and v3.4 software kits. Product Codes: 807300001-807300001-R, 804200…Systems with software version 3.2.x, 3.3,and 3.4 and v3.4 software kits. Product Codes: 807300001-807300001-R, 804200001-E, 807300001-E,807400001, 804200001, 806300001,1807400001,804200015, 804200001-M, 807400001-R, 07300001-M, 807300015-J, 804200014-R,804200014, 807400010, 804200001-R, 806300001-R, 807300015-RF,804200001-E, 806300001-R, 806300026, 807300001-R, 806300007,807300015 Serial Numbers: 101951631001,05207007001,101950286001,05207131001,05627, 05206042001, 0520641200, 1101950547001, 101950181001, 05206363001, 101950277001, 101951298001, 05207035001,05339,101950590001, 05206734001,101950229001,05206884001,102120770001,101950240001, 101950843001,105206471001,101950244001,05206115001,05206046001 05660,05036,06804119001,05205021001,06802011001,101950285001 101950192001 06801062001 102500002001 05208721001 05208168001 101950619001 05320041001 101951238001 05206001001 05206188001 101951628001 05208457001 05028 101950239001 977299 GREG RAUCH 6942 E. HUNTING H |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1813-2016%22
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