United StatesZimmer Tourniquet Systems A.T.S. 5000TS (model 60500010100) with software version v2.04 or prior, and A.T.S. 3200TS (model 60320010100) with software version v2.06 or prior, are affected. They were recalled because the device user interface (screen) may freeze or become unresponsive to touch when operating in certain non-English language settings, which may cause delay or extension while an alternate device is located.
What's being recalled
Brand Name: Zimmer Tourniquet Systems Product Name: A.T.S.¿ 5000TS Tourniquet Systems Model/Catalog Number: 60500010100 Software Version: Software version v2.04 or prior are within scope of the recall for A.T.S.¿ 5000TS Product Description: A.T.S 5000TS Tourniquet Systems Component: N/A
Brand Name: Zimmer Tourniquet Systems Product Name: A.T.S.¿ 3200TS Tourniquet Systems Model/Catalog Number: 60320010100 Software Version: Software version v2.06 or prior are within scope of the recall for A.T.S.¿ 3200TS Product Description: A.T.S 3200TS Tourniquet Systems Component: N/A
Recalling firm: Zimmer Surgical Inc, Dover, OH, United States.
How to identify it
Lot Code: Model No. 60500010100 ; UDI (01)00889024626454(11)240410(10)66722609(21)50066722609001; Lot No. 66722609 ; Serial No. 50066722609001 Model No. 60500010100 ; UDI "(01)00889024626454(11)240410(10)66722609(21)50066722609002; Lot No. 66722609 ; Serial No. 50066722609002 Model No. 60500010100 ; UDI "(01)00889024626454(11)240410(10)66722609(21)50066722609003" ; Lot No. 66722609 ; Serial No. 50066722609003 Model No. 60500010100 ; UDI "(01)00889024626454(11)240410(10)66722609(21)50066722609004" ; Lot No. 66722609 ; Serial No. 50066722609004 Model No. 60500010100 ; UDI "(01)00889024626454(11)240410(10)66722609(21)50066722609005" ; Lot No. 66722609 ; Serial No. 50066722609005 Model No. 60500010100 ; UDI "(01)00889024626454(11)240410(10)66722610(21)50066722610001" ; Lot No. 66722610 ; Serial No. 50066722610001 Model No. 60500010100 ; UDI "(01)00889024626454(11)240410(10)66722610(21)50066722610002" ; Lot No. 66722610 ; Serial No. 50066722610002 Model No. 60500010100 ; UDI "(01)00889024626454(11)240410(10)66722610(21)50066722610003" ; Lot No. 66722610 ; Serial No. 50066722610003 Model No. 60500010100 ; UDI "(01)00889024626454(11)240410(10)66722610(21)50066722610004" ; Lot No. 66722610 ; Serial No. 50066722610004 Model No. 60500010100 ; UDI "(01)00889024626454(11)240410(10)66722610(21)50066722610005" ; Lot No. 66722610 ; Serial No. 50066722610005 Model No. 60500010100 ; UDI "(01)00889024626454(11)240410(10)66722611(21)50066722611001" ; Lot No. 66722611 ; Serial No. 50066722611001 Model No. 60500010100 ; UDI "(01)00889024626454(11)240410(10)66722611(21)50066722611002" ; Lot No. 66722611 ; Serial No. 50066722611002 Model No. 60500010100 ; UDI "(01)00889024626454(11)240410(10)66722611(21)50066722611003" ; Lot No. 66722611 ; Serial No. 50066722611003 Model No. 60500010100 ; UDI "(01)00889024626454(11)240410(10)66722611(21)50066722611004" ; Lot No. 66722611 ; Serial No. 50066722611004 Model No. 60500010100 ; UDI "(01)00889024626454(11)240410(10)66722611(21)50066722611005"…
The hazard
Device user interface (screen) may freeze or become unresponsive to touch when operating in certain non-English language settings. Issue may cause delay or extension while alternate device is located.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
International distribution to the countries of Canada and EMEA only.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)