Recall Z-0082-2025
Datex-Ohmeda, Inc. · initiated July 12, 2024
Class I – dangerous or defective products that could cause serious health problems or death
Product
Aisys CS2. 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.
Codes / lots: GTIN: 00840682102292. Model Number: 1011-9050-000. All Serial Numbers. Not model or lot specific. All devices of the indicated products configured with the AGCO option are potentially affected.
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.
FDA-determined cause: Device Design
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.
Details
- Recall number
- Z-0082-2025
- Initiated
- July 12, 2024
- Posted by FDA
- October 18, 2024
- Product code
- BSZ – Gas-Machine, Anesthesia
- Quantity
- 15,739 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, Bermuda, Bolivia, BONAIRE, Bosnia and Herzegovina, Brazil, Brunei, Bulgaria, Cambodia, Cameroon, Canada, Chile, CHINA, Colombia, Costa Rica, Croatia, Curacao, Cyprus, Czech Republic, Denmark…
- Recalling firm
- Datex-Ohmeda, Inc., Madison, WI
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0074-2025 Class I | Aespire 7100, 7100 (Variant), and Aespire 7100 S/5 Protiva configurations. These…Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the… | 07/12/2024Open, Classified |
| Z-0075-2025 Class I | Aespire 100. This anesthesia gas machine is intended to provide general inhalation…Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the… | 07/12/2024Open, Classified |
| Z-0076-2025 Class I | Aespire 7900. This anesthesia gas machine is intended to provide general inhalation…Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the… | 07/12/2024Open, Classified |
| Z-0077-2025 Class I | Aespire View. This anesthesia gas machine is intended to provide general inhalation…Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the… | 07/12/2024Open, Classified |
| Z-0078-2025 Class I | Avance. This anesthesia gas machine is intended to provide general inhalation anesthesia…Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the… | 07/12/2024Open, Classified |
| Z-0079-2025 Class I | Amingo. OUS only.Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the… | 07/12/2024Open, Classified |
| Z-0080-2025 Class I | Avance CS2 and Avance CS2 Pro. These anesthesia gas machines are intended to provide…Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the… | 07/12/2024Open, Classified |
| Z-0081-2025 Class I | Aisys. This anesthesia gas machine is intended to provide general inhalation anesthesia…Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the… | 07/12/2024Open, Classified |
| Z-0083-2025 Class I | Aisys CS2 with Et Control. This anesthesia gas machine is intended to provide general…Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the… | 07/12/2024Open, Classified |
| Z-0084-2025 Class I | Auxiliary Common Gas Outlet (ACGO) conversion/install kits sold under product names CONV…Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the… | 07/12/2024Open, Classified |