FDA Medical Device Recalls (openFDA)
Custom Ultrasonics, Inc.: Custom Ultrasonics System 83 Plus 2 and Plus 9 Endoscope Washer/Disinfector.
- Recall number
- Z-0426-2014
- Recalling firm
- Custom Ultrasonics, Inc.
- Product
- Custom Ultrasonics System 83 Plus 2 and Plus 9 Endoscope Washer/Disinfector.
- Status
- Terminated
- Initiated
- 2013-03-12
- Posted
- 2013-11-27
- Terminated
- 2014-06-26
- Reason
- Certain System 83 Plus 2 and System 83 Plus 9 units running the Windows 7 operating system were not fully validated prior to distribution.
- Root cause
- Software design
- Action
- A notification letter, dated February 26, 2013, was sent to direct accounts to inform them of the recall and that technicians would visit facilities to replace the Windows 7 operating system with an appropriately validated Windows XP operating system.
- Quantity
- 118
- Distribution
- Worldwide Distribution: USA (nationwide) and Internationally to: Canada, Slovakia Republic, Sydney and Peru.
- Lot, serial or model codes
- Multiple serial numbers
- 510(k) numbers
- ["K122172","K983017"]
- PMA numbers
- not on file
- Product code
- KOG
- Firm FEI
- 2523209
- Firm city
- Ivyland
- Firm state
- PA
- 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