Reported Dec 4, 2013 · Terminated

Custom Ultrasonics System 83 Plus 2 and Plus 9 Endoscope Washer/Disinfector.

Custom Ultrasonics, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Custom Ultrasonics, Inc. · 144 Railroad Dr · Ivyland, PA · 18974-1449

Is this the product you have?

  • Custom Ultrasonics System 83 Plus 2 and Plus 9 Endoscope Washer/Disinfector.
Lot codes and dates
  • Multiple serial numbers
Amount recalled
118

Where it was sold

  • Nationwide

Why it was 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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jun 26, 2014 · Data as of Sep 19, 4:48 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.