FDA-Device2014-12-31Class II
GETINGE 46-SERIES Medical Washer-Disinfector, Models 46-4 and 46-5, with PACS 300/350 Control Series with dryer --- Class II, exempt from 510(k) requirements. For use in healthcare facilities and laboratories where reusable items such as instruments, utensils, anesthesia sets, and glassware are handled for decontamination purposes.
Getinge Disinfection Ab
Hazard
Getinge Disinfection AB received complaints regarding sediment residuals in the manifold of the washer and disinfector of Getinge 46-Series (CM302) with PACS 300/350 control. After performing detailed root cause analysis, the firm has identified the problem as insufficient water flow throughout the manifold due to formation of air pockets where sedimentation may occur.
Sold states
Distributed US (nationwide) and the country of Canada.
Affected count
551 total: USA: 547 units, Canada: 4 units
Manufactured in
Ljungadalsgatan 11, Vaxjo, Sweden
Products
GETINGE 46-SERIES Medical Washer-Disinfector, Models 46-4 and 46-5, with PACS 300/350 Control Series with dryer --- Class II, exempt from 510(k) requirements. For use in healthcare facilities and laboratories where reusable items such as instruments, utensils, anesthesia sets, and glassware are handled for decontamination purposes.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0852-2015Don't want to check this manually?
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