FDA Device recall Z-0426-2014
Custom Ultrasonics System 83 Plus 2 and Plus 9 Endoscope Washer/Disinfector
- FDA Device
- Class II
- terminated
- Published 2013-12-04
On 2013-12-04 the FDA classified a Class II recall of Custom Ultrasonics System 83 Plus 2 and Plus 9 Endoscope Washer/Disinfector by Custom Ultrasonics, citing certain System 83 Plus 2 and System 83 Plus 9 units running the Windows 7 operating system were not fully validated prior to distribution.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0426-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-03-12 |
| Published | 2013-12-04 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Custom Ultrasonics |
| Distribution | US |
Product
Custom Ultrasonics System 83 Plus 2 and Plus 9 Endoscope Washer/Disinfector.
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.
Identifiers
| code_info | Multiple serial numbers |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0426-2014%22
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