Steris Reliance Vision Washer/Disinfector Recalled for Fire Risk
Steris is recalling Reliance Vision Single-Chamber Washer/Disinfector units because a faulty electrical contactor may cause the drying chamber to overheat, potentially leading to smoke or fire.
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 risk of fire and smoke, which constitutes a significant injury/property-damage hazard under the rubric for Severe (Score 4) recalls.
Plain-English summary
Steris Corporation is recalling the Reliance Vision Single-Chamber Washer/Disinfector. The recall involves 3,405 units distributed worldwide, including the United States and numerous international markets.
The recall is due to a potential malfunction in the electrical contactor component located in the drying chamber. This malfunction may cause the heating elements to overheat, which can result in smoke and/or fire. The device is intended for use in healthcare facilities for the cleaning and intermediate level disinfection of soiled reusable utensils, trays, glassware, bedpans, urinals, rubber and plastic goods, and simple hard-surfaced rigid surgical instruments.
Healthcare facilities should stop using the affected units immediately. Users should check the serial number of their device against the list of affected serial numbers provided in the official recall notice. If the serial number matches, the facility should contact Steris Corporation for instructions on repair or replacement.
The recalled product
- Product
- Reliance Vision Single-Chamber Washer/Disinfector - Product Usage: intended for use in the cleaning and intermediate level disinfection of soiled reusable utensils, trays, glassware, bedpans and urinals, rubber and plastic goods, simple hard-surfaced rigid surgical instruments…
- Manufacturer
- Steris Corporation
- Affected units
- 3,405
Distribution
Distributed nationwide across the United States.
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