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Terminated

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.

FDA Recall Z-1813-2016 · Posted None

Recalling FirmVolcano Corporation
Recall StatusTerminated
Product CodeOBJ
Date Initiated2016-04-25
Date Terminated2018-01-02
Product Quantity5875 (2685 in US; 3190 ROW)

Reason for Recall

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

Firm Action

The firm, Philips, sent an "URGENT MEDICAL DEVICE FIELD CORRECTIVE ACTION" letter dated 4/25/2016 to its customers beginning April 29, 2016 which include a technical service bulletin to explain how to assure the incompatibility issue does not affect system performance. The customers were instructed to do the following: -If you have an Impacted System but it is not connected to a network, this issue does not affect your system. Additionally, if network scans are not performed, this issue does not affect your system. -If you have an Impacted System that is connected to a network and staff performs network scans while the Impacted System is in operation, this issue does affect you and the circumstances exist for a manual reboot to occur during an active procedure. To avoid this, the following corrections must promptly be taken: 1. Disconnect your Impacted Systems from the facilities network. If you need to reconnect it while not being used in a procedure, make sure it is disconnected again before starting any procedure; OR 2. Do not permit your staff to perform network scans while the Impacted Systems are in operation. -Please complete, sign, and return the attached form indicating that you received this Field Corrective Action notification via Fax to Volcano Customer Service at (916) 638-8812 or email to [email protected]. If you have any questions, please call (800) 228-4728, option 5.

Root Cause

Software in the Use Environment

Distribution Pattern

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,

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K123898VOLCANO S5/S5I INTRAVASCULAR ULTRASOUND IMAGING AND PRESSURE SYSTEMVolcano Corporation · 2013-01-14K071554VOLCANO S5/S5I INTRAVASCULAR IMAGING AND PRESSURE SYSTEMVolcano Corporation · 2008-01-04

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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