Advanced Sterilization Products Recalls EVOTECH Endoscope Cleaner Due to Smoke Risk
Advanced Sterilization Products is recalling 761 EVOTECH Endoscope Cleaner and Reprocessor systems because a circuit board malfunction can cause smoke to emanate from the device.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall involves a medical device with a reported malfunction causing smoke, which presents a fire and burn hazard. This aligns with the rubric criterion for 'significant injury/property-damage reports' or high-risk product defects, warranting a Severe classification.
Plain-English summary
Advanced Sterilization Products (ASP) is recalling the EVOTECH Endoscope Cleaner and Reprocessor System, P/N 50004. The device is designed to automatically clean and high-level disinfect flexible, submersible video or fiber-optic endoscopes. A total of 761 units were distributed nationwide.
The recall was initiated because ASP received reports of smoke emanating from the system. This issue is attributed to a circuit board malfunction that may occur in the Channel Control Manifold sub-assembly. The source text does not report any injuries or illnesses associated with this malfunction.
Healthcare facilities and users should stop using the affected units immediately. ASP has provided a list of specific batch numbers associated with the recall. Users should verify their device's batch number against the provided list and contact the manufacturer for further instructions on repair or replacement.
The recalled product
- Product
- EVOTECH Endoscope Cleaner and Reprocessor System, P/N 50004. Designed to automatically clean and high-level disinfect flexible, submersible video or fiber-optic endoscopes.
- Manufacturer
- Advanced Sterilization Products
- Hazard
- Affected units
- 761
Distribution
Distributed nationwide across the United States.
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