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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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.
- Hazard
- 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.
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