FDA Medical Device Recalls (openFDA)
Volcano Corporation: 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.
- Recall number
- Z-2345-2012
- 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.
- Status
- Terminated
- Initiated
- 2012-08-24
- Posted
- 2012-09-10
- Terminated
- 2014-11-25
- Reason
- 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
- 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
- 1020 units
- Distribution
- Worldwide Distribution.
- Lot, serial or model codes
- All units of these models. Models/Part Numbers: 435-0607.01, 435-0607.04, 435-0602.01, 435-0602.02
- 510(k) numbers
- ["K082229","K111706"]
- PMA numbers
- not on file
- Product code
- IYO
- Firm FEI
- 2939520
- Firm city
- Rancho Cordova
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28