Amingo. OUS only.
FDA device recall Z-0079-2025 · posted 2024-10-18 · Open, Classified
Recall details
- Recalling firm
- Datex-Ohmeda, Inc.
- 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.
- Action taken
- GE Healthcare notified consignees on about 07/12/2024 via letter. Consignees were instructed to ensure all potential users complete the Preoperative Checkout procedure in its entirety, as detailed in the URM, make sure that the breathing circuit is correctly connected, only connect an auxiliary manual breathing circuit to the ACGO port, place the included addendum with the URM and inspect all potentially affected devices for the presence of covers applied to the ACGO Port and ACGO Switch. Additionally, customers were requested to complete and return the response form.
- Root cause
- Device Design
- Status
- Open, Classified
- Product code
- N/A
- Quantity affected
- 77 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Aland Islands, ALBANIA, Algeria, Argentina, Australia, Austria, Azerbaijan, BAHAMAS, Bahrain, Bangladesh, BARBADOS, BELARUS, Belgium, Benin,
- Date initiated
- 2024-07-12
- Date posted
- 2024-10-18
- Location
- Madison, WI
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