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Recall Observatory FDA recall evidence

Device product

Aespire 100. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.

Z-0075-2025

July 12, 2024

Class I

Product summary

Firm
Datex-Ohmeda, Inc.
Event
Event 95045
Status
Ongoing
Classification
Class I
Quantity
N/A
Official record key
device-enforcement:Z-0075-2025

Official wording

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

Code information: GTIN: 00840682102261

Distribution pattern: 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, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, ETHIOPIA, Falkland Islands, Finland, France, French Polynesia, Gabon, Georgia, Germany, Ghana, Gilbrator, Greece, Guadeloupe, Guatemala, Guyana, Honduras, Hong Kong, Hungary, ICELAND, India, Indonesia, Iran, IRAQ, Ireland, Israel, Italy, Jamaica, JAPAN, Jordan, Kazakhstan, KENYA, Korea (Republic Of), Korea, Republic of, Kuwait, Laos, LATVIA, Lebanon, Libya, LITHUANIA, Macedonia, Malaysia, Maldives, Malta, MAURITIUS, Mexico, Moldova, Montenegro, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, North Macedonia, Norway, Oman, PAKISTAN, Palestine, State of, Panama, Paraguay, Peru, Philippines, Poland, Portugal, PUERTO RICO, Qatar, REUNION, ROMANIA, Russia, San Marino, Saudi Arabia, Senegal, Serbia, SINGAPORE, Slovakia, Slovenia, South Africa, Spain, Sudan, Sweden, Switzerland, Syria, Taiwan, Tanzania, THAILAND, Trinidad and Tobago, Tunisia, Turkey, T¿rkiye, Uganda, UKRAINE, United Arab Emirates, United Kingdom, Uruguay, UZBEKISTAN, Venezuela, Vietnam, Yemen.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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