Getinge 46-Series Washer-Disinfectors Recalled for Overheating Risk
Getinge Disinfection is recalling 46-Series medical washer-disinfectors due to a possible overheating hazard. The voluntary field safety correction affects 143 units distributed in the US and Canada.
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 (overheating) where no specific injuries or illnesses have been reported in the source text, fitting the criteria for a High severity score.
Plain-English summary
Getinge Disinfection AB has initiated a voluntary field safety correction for the Getinge 46-Series electrically-heated Washer Disinfectors. The recall is due to a possible overheating hazard associated with the devices.
The affected products are used in healthcare facilities to decontaminate reusable items such as instruments, utensils, anesthesia sets, and glassware. A total of 143 units are involved in this recall, with 142 units distributed domestically in the United States and 1 unit distributed internationally in Canada. The specific model is 46-4, with serial numbers ranging from SEV0521184 to SEV0838137.
Healthcare facilities should stop using the affected units and contact Getinge Disinfection for further instructions regarding the field safety correction.
The recalled product
- Product
- Getinge 46-Series Medical Washer-Disinfectors, Listing # E208196 Product Usage: The washer disinfector is used in healthcare facilities where reusable items such as instruments, utensils, anesthesia sets, and glassware are handled for decontamination purposes.
- Manufacturer
- Getinge Disinfection
- Hazard
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 (2)
- Model # 46-4
- Serial # range SEV0521184-SEV0838137
Distribution
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