Firm became aware of software issues related to most recent firmware update which could result in loss of patient tissue.
Reason for recall: Firm became aware of software issues related to most recent firmware update which could result in loss of patient tissue. Distribution: Worldwide - US Nationwide distribution in the states of Idaho and Ohio. The countries of France, Australia, Belgium, China, Germany, Spain, UK, Hong Kong, Ireland, Italy, Japan, Netherlands, Norway, Poland, Singapore. Quantity: 2 Lot/code info: Model No: 1491950C4US UDI-DI: (01)04049188139030 Serial Numbers 12835, 12854
04049188139030
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.