Flow sensors that may be installed in the following GEHC anesthesia machines: (1) Aestiva MRI, GTIN 0080682102339; (2) Aestiva 7900; (3) Aestiva 7100; (4) Aespire System Carestation, S/5 Protiva Config., Aespire 100 Compact Wall Mount (Aespire 7100); (5) S/5 Aespire 7900; (6) Aespire View; (7) Avance; (8) Avance CS2, GTIN 00840682102292; (9) Aisys; (10) Aisys CS2, GTIN 00840682102322; (11) Amingo; (12) 9100 NXT Config, Aelite NXT; (13) Protiva 7100;
Reported: October 6, 2021 Initiated: August 2, 2021 #Z-2596-2021
Product Description
Flow sensors that may be installed in the following GEHC anesthesia machines: (1) Aestiva MRI, GTIN 0080682102339; (2) Aestiva 7900; (3) Aestiva 7100; (4) Aespire System Carestation, S/5 Protiva Config., Aespire 100 Compact Wall Mount (Aespire 7100); (5) S/5 Aespire 7900; (6) Aespire View; (7) Avance; (8) Avance CS2, GTIN 00840682102292; (9) Aisys; (10) Aisys CS2, GTIN 00840682102322; (11) Amingo; (12) 9100 NXT Config, Aelite NXT; (13) Protiva 7100;
Reason for Recall
The flow sensors built prior to June 2021 could have damaged tubes with small punctures or cuts that could cause leaks resulting in incorrect anesthesia machine tidal volumes potentially leading to over-delivery of volume to the patient.
Details
- Recalling Firm
- GE Healthcare, LLC
- Units Affected
- Estimated 310,072 flow sensors
- Distribution
- Distribution was nationwide, including PR. Foreign distribution was made to Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belgium, Bermuda, Bolivia, Bosnia and Herzegovina, Brazil, Brunei, Bulgaria, Cambodia, Canada, Chile, China, Colombia, Costa Rica, Cote D'lvoire, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Ethiopia, Fiji, Finland, France, Georgia, Germany, Ghana, Greece, Guatemala, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jersey, Jordan, Kazakhstan, Kenya, Korea, Kosovo, Kuwait, Laos, Latvia, Lebanon, Libya, Lithuania, Macedonia, Madagascar, Malaysia, Maldives, Mali, Malta, Mauritius, Mexico, Moldova, Montenegro, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Niger, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Rwanda, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom Uruguay, Venezuela, Vietnam, and Yemen.
- Location
- Waukesha, WI
Frequently Asked Questions
What product was recalled? ▼
Flow sensors that may be installed in the following GEHC anesthesia machines: (1) Aestiva MRI, GTIN 0080682102339; (2) Aestiva 7900; (3) Aestiva 7100; (4) Aespire System Carestation, S/5 Protiva Config., Aespire 100 Compact Wall Mount (Aespire 7100); (5) S/5 Aespire 7900; (6) Aespire View; (7) Avance; (8) Avance CS2, GTIN 00840682102292; (9) Aisys; (10) Aisys CS2, GTIN 00840682102322; (11) Amingo; (12) 9100 NXT Config, Aelite NXT; (13) Protiva 7100;. Recalled by GE Healthcare, LLC. Units affected: Estimated 310,072 flow sensors.
Why was this product recalled? ▼
The flow sensors built prior to June 2021 could have damaged tubes with small punctures or cuts that could cause leaks resulting in incorrect anesthesia machine tidal volumes potentially leading to over-delivery of volume to the patient.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 6, 2021. Severity: Moderate. Recall number: Z-2596-2021.
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