Z-2345-2012Class II

Volcano brand Intravascular Ultrasound, Volcano s5/s5i Family Software Version 3.2.1 or 3.2.2, Models/Part...

Name: Z-2345-2012 Volcano brand Intravascular Ultrasound, Volcano s5/s5i Family Software Version 3.2.1 or 3.2.2, Models/Part...
Creator: Volcano Corporation
Published: 2012-08-24
License: https://open.fda.gov/license/

Volcano Corporation / initiated 2012-08-24 / Terminated / root cause: software

FDA source

Volcano Corporation began a recall of Volcano brand Intravascular Ultrasound, Volcano s5/s5i Family Software Version 3.2.1 or 3.2.2, Models/Part Numbers: 435-0607.01, 435-0607.04, 435-0602.01... on 2012-08-24. FDA classified it as Class II and gives the reason as "The display on the system has the potential to change. In house testing eventually identified the unique sequence of events that must occur in order for this issue to manifest itself". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2345-2012
Classification: Class II
Status: Terminated
Initiated: 2012-08-24
Posted: 2012-09-10
Terminated: 2014-11-25
Recalling firm: Volcano Corporation
Product: Volcano brand Intravascular Ultrasound, Volcano s5/s5i Family Software Version 3.2.1 or 3.2.2, Models/Part Numbers: 435-0607.01, 435-0607.04, 435-0602.01, 435-0602.02; Product is manufactured and distributed by Volcano Corporation, Rancho Cordova, CA. Medical device for use in imaging of histology.
Product code: IYO System, Imaging, Pulsed Echo, Ultrasonic
Reason for recall: The display on the system has the potential to change. In house testing eventually identified the unique sequence of events that must occur in order for this issue to manifest itself.
Root cause tag: software
FDA root cause: Software design
Action: Volcano Corporation sent an "IMPORTANT FIELD CORRECTIVE ACTION" letter dated August 24, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. Contact your local Volcano sales representative or Volcano Customer Service for questions regarding this recall.
Quantity in commerce: 1020 units
Distribution: Worldwide Distribution.
Product codes and lots: All units of these models. Models/Part Numbers: 435-0607.01, 435-0607.04, 435-0602.01, 435-0602.02

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2345-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2345-2012	Class II	Terminated	Voluntary: Firm initiated	2012-09-19	2012-09-10

Product code IYO

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)