Custom Ultrasonics System 83 Plus 2 and Plus 9 recall
Custom Ultrasonics System 83 Plus 2 and Plus 9 Endoscope Washer/Disinfector.
Why was Custom Ultrasonics System 83 Plus 2 and Plus 9 recalled?
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 should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Multiple serial numbers
- Product
- Custom Ultrasonics System 83 Plus 2 and Plus 9 Endoscope Washer/Disinfector.
- Recalling firm
- Custom Ultrasonics, Inc.
- Quantity
- 118
- Distribution
- Worldwide Distribution: USA (nationwide) and Internationally to: Canada, Slovakia Republic, Sydney and Peru.
- Recall date
- December 4, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)