Custom Ultrasonics System 83 Plus 2 and Plus 9 Endoscope Washer/Disinfector.
FDA device recall Z-0426-2014 · posted 2013-11-27 · Terminated
Recall details
- Recalling firm
- Custom Ultrasonics, Inc.
- Reason for recall
- Certain System 83 Plus 2 and System 83 Plus 9 units running the Windows 7 operating system were not fully validated prior to distribution.
- Action taken
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- KOG
- Quantity affected
- 118
- Distribution
- Worldwide Distribution: USA (nationwide) and Internationally to: Canada, Slovakia Republic, Sydney and Peru.
- Date initiated
- 2013-03-12
- Date posted
- 2013-11-27
- Date terminated
- 2014-06-26
- Location
- Ivyland, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SYSTEM 83 PLUS (K122172) | Custom Ultrasonics | 2013-01-25 |
| MODIFICATION TO SYSTEM 83 PLUS (K983017) | Custom Ultrasonics | 1998-09-22 |