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Recall Observatory FDA recall evidence

Device product

Getinge 86-Series-Medical Washer-Disinfector Part Number: S-86662003 Product Usage: Usage: The Getinge 86 Series Medical Washer-Disinfector is designed for use in healthcare facilities and laboratories where reusable items such as instruments, utensils, anesthesia sets, and glassware are handled for decontamination purposes.

Z-1777-2019

May 20, 2019

Class II

Product summary

Firm
Maquet Cardiovascular Us Sales, Llc
Event
Event 82975
Status
Terminated
Classification
Class II
Quantity
4 units
Official record key
device-enforcement:Z-1777-2019

Official wording

Reason: Possibility that inlet pump hose of the Washer Disinfector Getinge 86-Series (S-8666, S-8668) might collapse during use result in low water pressure within the circulation system and, in the worst case scenario, can result in the contents of the Washer Disinfector not being cleaned properly after finished process.

Code information: Serail Numbers: WAA088731, WAA089124 , WAA089128, WAA089586

Distribution pattern: Worldwide Distribution - US Nationwide GA, IL, IN, MI, NC, OR, PA, VA Foreign: Australia, Canada, China, France, Germany, India, Japan, Korea, Netherlands, Saudi Arabia, South Africa, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, Ukraine

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Possibility that inlet pump hose of the Washer Disinfector Getinge 86-Series (S-8666, S-8668) might collapse during use result in low water pressure within the circulation system and, in the worst case scenario, can result in the contents of the Washer Disinfector not being cleaned properly after finished process.