Reliance Synergy Washer/Disinfector fire hazard due to electrical contactor malfunction
Steris Corporation is recalling Reliance Synergy Washer/Disinfector units due to a malfunctioning electrical contactor that can cause heating elements to overheat, creating a fire risk. Affected units may generate smoke and fire in the drying chamber.
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: FDA Class II medical device with potential fire and overheat hazard in the drying chamber due to electrical contactor malfunction; no reported illnesses or injuries.
Plain-English summary
Steris Corporation is recalling Reliance Synergy Washer/Disinfector units nationwide and internationally. The recall affects approximately 3,863 units (2,776 in the US and 1,087 outside the US). The affected serial numbers are listed by the FDA.
The electrical contactor component in the drying chamber of affected units may malfunction. When this occurs, the heating elements in the drying chamber can overheat, potentially resulting in smoke and/or fire.
These medical devices have been distributed nationwide in the US and to other countries worldwide. Healthcare facilities and organizations using these devices should check the provided serial numbers to determine if their equipment is affected.
Users should immediately stop using affected units and contact Steris Corporation for service or replacement. Do not attempt to repair or operate units if you suspect the electrical contactor component is malfunctioning.
The recalled product
- Product
- Reliance Synergy Washer/Disinfector
- Manufacturer
- Steris Corporation
- Category
- Medical Device
Distribution
Distributed nationwide across the United States.
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