FDAFDA · Food and drugs·Recall number Z-0426-2014
Custom Ultrasonics System 83 Plus 2 and Plus 9 Endoscope Washer/Disinfector.
Published December 4, 2013 · Recall initiated: March 12, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Certain System 83 Plus 2 and System 83 Plus 9 units running the Windows 7 operating system were not fully validated prior to distribution.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Custom Ultrasonics, Inc.
- Distributor
- Worldwide Distribution: USA (nationwide) and Internationally to: Canada, Slovakia Republic, Sydney and Peru.
- Lot
- Multiple serial numbers
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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