FDA Medical Device Recalls (openFDA)
Volcano Corporation: Volcano s5 Imaging system, Ultrasound pulsed echo imaging system. Product consists of the CPU, control console, monitor, printer, and patient interface module (PIM)
- Recall number
- Z-1190-2007
- Recalling firm
- Volcano Corporation
- Product
- Volcano s5 Imaging system, Ultrasound pulsed echo imaging system. Product consists of the CPU, control console, monitor, printer, and patient interface module (PIM)
- Status
- Terminated
- Initiated
- 2007-04-02
- Posted
- 2007-08-23
- Terminated
- 2008-06-03
- Reason
- During emissions testing, it was discovered that the product exceeds emissions limits for electromagnetic compatibility.
- Root cause
- Other
- Action
- The firm notified its customers by letter beginning April 2, 2007, and started replacing the monitor with appropriate replacement parts.
- Quantity
- 351 units worldwide
- Distribution
- Product was distributed to health care facilities nationwide and to distributors in Europe (via subsidiary), Japan (via subsidiary), Latin America and Asia (third party distributors).
- Lot, serial or model codes
- Device listing A863634, part number 804200-100. monitor part number that is being replaced: 90X0315A. All units shipped on or before November 2005.
- 510(k) numbers
- ["K051920"]
- 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