Products in distribution were found by FDA to be to be substantially different from the current cleared 510(k)s with a major change or modification to the device s intended use.
Reason for recall: Products in distribution were found by FDA to be to be substantially different from the current cleared 510(k)s with a major change or modification to the device s intended use. Distribution: US Nationwide, Czech Republic, Belgium, Portugal, Canada, Saudi Arabia, Netherland, France, Switzerland, Latvia, UK, Spain, Germany, Philippines, Australia, Malaysia, Jamaica, Slovenia, Brazil, Taiwan, Denmark, Sweden, Singapore, Romania, Poland, Barbados, Mexico, Guatemala, Chile, Ireland, Italy, Panama Lot/code info: 1) Model No. 180011, UPC 8183923010138, Lot Numbers: 19072506; 2) Model No. P180011, UPC 810018097523, Lot Numbers: 4107175, 4107176, 4110015, 4312056; 3) Model No. 180020ST, UPC 840368511998, Lot Numbers: 4209011; 4) Model No. P180003ST, UPC 810018097493, Lot Numbers: 4105121; 5) Model No. P180005ST, UPC 810018097462, Lot Numbers: 4104054; 6) Model No. P180010ST, UPC 810018097646, Lot Numbers: 4105081, 4108076, 4111055, 4302012, 4303050; 7) Model No. P180020ST, UPC 810018098636, Lot Numbers: 4110014, 4110055, 4301004, 4303048; 8) Model No. P180030ST, UPC 810062435333, Lot Numbers: 4302041; 9) Model No. P180060ST, UPC 810062435340, Lot Numbers: 4302042; 10) Model No. P180011T, UPC 810018098957, Lot Numbers: 4108002
8183923010138, 810018097523, 840368511998, 810018097493, 810018097462, 810018097646, 810018098636, 810062435333, 810062435340, 810018098957
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.