High FDA (Devices)·Z-0426-2014·Announced 2013-12-04

Custom Ultrasonics Endoscope Washer/Disinfector Recalled for Incomplete Validation

Custom Ultrasonics is recalling 118 System 83 Plus 2 and Plus 9 Endoscope Washer/Disinfector units because they were not fully validated prior to distribution.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a lack of validation for a medical device, which poses a risk of harm, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Custom Ultrasonics, Inc. is recalling 118 units of the System 83 Plus 2 and System 83 Plus 9 Endoscope Washer/Disinfector. The recall involves units running the Windows 7 operating system that were not fully validated prior to distribution.

The affected devices were distributed nationwide in the United States and internationally to Canada, Slovakia, Sydney, and Peru. The recall is classified as Class II by the FDA.

Consumers and healthcare facilities should stop using the affected devices and contact Custom Ultrasonics, Inc. for further instructions.

The recalled product

Product: Custom Ultrasonics System 83 Plus 2 and Plus 9 Endoscope Washer/Disinfector.
Manufacturer: Custom Ultrasonics, Inc.
Category: Medical Device — Endoscope Washer/Disinfector
Hazard: incomplete-validation
Affected units: 118

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

Multiple serial numbers

Distribution

Distributed nationwide across the United States.

Same manufacturer · Custom Ultrasonics, Inc.

See all →

High
Custom Ultrasonics System 83 Plus Endoscope Washer Recall Issued
FDA (Devices) · 2016-07-13

Same hazard · incomplete validation