Steris Recalls AMSCO 3000 Series Washer/Disinfector Units Due to Software Defect
Steris Corporation is recalling 11 AMSCO 3000 Series Washer/Disinfector units because a software defect may prevent intended processing cycles, risking inadequate cleaning or damage to medical instruments.
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 involves a risk-of-harm product (medical device) where inadequate disinfection could lead to patient harm, but no specific injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria for theoretical risk.
Plain-English summary
Steris Corporation is recalling 11 units of the AMSCO 3000 Series Washer/Disinfector Model # 3052. The recall is due to a software defect that may cause the systems to fail to process the originally intended cycle.
This malfunction could result in damage to the various medical devices and instruments processed in the washer/disinfector, or it could lead to inadequate cleaning or disinfection. The affected units were distributed to 28 U.S. states and seven foreign countries, including Bahrain, Brazil, Canada, China, Saudi Arabia, South Korea, and Taiwan.
Healthcare facilities and users should stop using the affected units and contact Steris Corporation for further instructions. The specific serial numbers for the recalled units are listed in the official recall documentation.
The recalled product
- Product
- AMSCO 3000 Series Washer/Disinfector Model # 3052
- Manufacturer
- Steris Corporation
- Affected units
- 11
Distribution
Part of a larger recall action
This product is one of 2 recalled by Steris Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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