Recall StatusTerminated
Date Initiated2022-06-01
Date Terminated2024-10-21
Product Quantity5,372 devices
Reason for Recall
There is a potential reversal of the O2 and air cylinder pressure transducer connections.
Firm Action
The recalling firm issued letters beginning 6/1/2022 via traceable means to the Chief of Anesthesia, Director of Biomedical/Clinical Engineering, and Health Care Administrator/Risk Manager at their consignee locations. The letter was flagged that consignees should ensure all potential users in their facility are made aware of this safety notification and the recommended actions. The letter provided the affected products, safety issue, and actions to be taken. The customer was informed they could continue to use the anesthesia system by following the instructions provided in the letter prior to use. A Medical Device Notification Acknowledgement Response form was enclosed to acknowledge receipt and understanding of the notice. The consignee was to record their anesthesia system serial number, whether it passed or failed the test, and the date of the test. The response form was supposed to be completed and returned no later than 30 days from receipt.
Root Cause
Process control
Distribution Pattern
Worldwide Distribution. US nationwide, Australia, Austria, Belgium, Bolivia, Brazil, Canada, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Ireland, Italy, Japan, Kenya, Korea, Kuwait, Malaysia, Mexico, Montenegro, Nepal, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, and Uruguay.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
K172045Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100, Aespire 7100, Aespire 7900, Aespire View, Avance, Avance CS2, Aisys, Aisys CS2Datex-Ohmeda, Inc. · 2017-11-03
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.