Datex-Ohmeda, Inc.: Aespire 7100, 7100 (Variant), and Aespire 7100 S/5 Protiva configurations. These anesthesia gas machines are intended to provide general inhalation anesthesia and ventilatory suppo

Hazard

Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.

Details from the source

Reason for recall: Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port. Distribution: Worldwide distribution - US Nationwide and the countries of Aland Islands, ALBANIA, Algeria, Argentina, Australia, Austria, Azerbaijan, BAHAMAS, Bahrain, Bangladesh, BARBADOS, BELARUS, Belgium, Benin, Bermuda, Bolivia, BONAIRE, Bosnia and Herzegovina, Brazil, Brunei, Bulgaria, Cambodia, Cameroon, Canada, Chile, CHINA, Colombia, Costa Rica, Croatia, Curacao, Cyprus, Czech Republic, Denmark, Dominic Quantity: 20,097 units Lot/code info: a. Aespire 7100 - GTIN: 00840682102261. Model Number: 1009-9000-000. All Serial Numbers. b. Aespire 7100 (Variant) - GTIN: 00840682102261. Model Numbers: 1009-9101-000 and 1009-9101-000. All Serial Numbers. c. Aespire 7100 S/5 Protiva - No GTIN. Model Number: 1009-9004-000. All Serial Numbers. Not model or lot specific. All devices of the indicated products configured with the AGCO option are potentially affected.

UPC codes

00840682102261

Source

Official record: FDA (Device enforcement) ↗

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