Reported Jun 25, 2014 · Terminated
Spacelabs Healthcare Ventilator Flexport Interface, Model 90436A-07
Spacelabs Healthcare Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Spacelabs Healthcare Inc · 35301 SE Center St · Snoqualmie, WA · 98065-9216
Is this the product you have?
- Spacelabs Healthcare Ventilator Flexport Interface, Model 90436A-07
- Lot codes and dates
- Serial Numbers Distributed in the US
436A000660436A000663436A000664436A000666436A000667436A000669436A004306436A004307436A004308436A004309436A004310436A006122436A006123436A006441436A006442436A006443436A006444436A006452436A006573436A006589436A006590436A006591436A006592436A006593436A006594436A006595436A0065966A006597436A006598436A006599436A006600436A006601436A00670436A006966 436A01020436A02086436A02087436A02088436A02234436A02246436A02247436A02281436A02282436A02283436A03237 and 436A03238. Serial
- Numbers Distributed Outside the US
108 of 108 codes
436A003628436A003629436A003630436A003631436A003632436A003633436A003634436A003635436A003636436A003637436A003638436A003639436A003640436A003644436A003645436A003646436A003647436A004162436A004166436A004197436A004198436a005205436a005471436a005472436A005638436A005641436A005642436A006087436A006088436A006151436A006193436A006248436A006249436A006250436A006262436A006389436A006390436A006397436A006445436A006446436A006522436A006523436A006524436A006570436A006571436A006572436A006609436A006610436A006611436A006612436A006613436A006614436A006616436A006617436A006618436A006619436A006620436A006621436A006624436A006625
- Serial Numbers Distributed in the US
- Amount recalled
- 46 units distributed within the US; 108 units distributed outside the US.
Where it was sold
Why it was recalled
Spacelabs Healthcare is voluntarily recalling the Hamilton Galileo Ventilator Flexport, Model 90436A-07, where the monitored Minute Volumes (Vmin) has been reported at one time to reach ten times the actual value on the bedside monitor.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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