Datascope Corp.: CS100 IABP. Software Version CS100 IABP Q.01.

Hazard

The firm has identified that the battery runtime and cycle specifications contained in the devices Instructions for Use (IFU) need to be updated.

Details from the source

Reason for recall: The firm has identified that the battery runtime and cycle specifications contained in the devices Instructions for Use (IFU) need to be updated. Distribution: Worldwide distribution - US Nationwide and the countries of Afghanistan, Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Barbados, Belarus, Belgium, Bolivia, Bosnia And Herzegovina, Brazil, Bulgaria, Cambodia, Canada, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Dominican Republic, Ecuador, Egypt, El Salvador , Estonia, France, Georgia, Germany, Gha Quantity: 10,897 units Lot/code info: All Model No; All UDI; All Serial No.

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.