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Open, Classified

Flow sensors kept as stand-alone user replaceable spare parts for the GEHC anethesia machines: 2089610-001 FLOW SENSOR, LEGACY VAR ORF BCG (blue, cleanable) 2089610-001-S FLOW SENSOR, LEGACY VAR ORF BCG, SERVICE (blue, cleanable) 2087640-001 FLOW SENSOR, LEGACY VAR ORF AUTOCLAVABLE BCG (gray, autoclavable) 2087640-001-S FLOW SENSOR, LEGACY VAR ORF AUTOCLAVABLE BCG, SERVICE (gray, autoclavable) 2096513-001-S FLOW SENSOR ASSEMBLY 5697309 R-FMI34109-FLOW SENSOR, LEGACY VAR ORF BCG 5697310 R-FMI34109-FLOW SENSOR, LEGACY VAR ORF AUTOCLAVABLE BCG

FDA Recall Z-2595-2021 · Posted None

Recalling FirmGE Healthcare, LLC
Recall StatusOpen, Classified
Product CodeBSZ
Date Initiated2021-08-02
Product QuantityEstimated 310,072 flow sensors

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.

Firm Action

The recalling firm issued Urgent Medical Device Correction letters on 8/2/2021 via FedEx explaining the safety issue. This letter informs the customer of the issue and provides safety instructions, including requesting the consignee inspect all inventory of flow sensors. GE Healthcare will replace the flow sensors indicated on returned customer response forms, when applicable. The consignee will be responsible for replacing the flow sensor. The letter was sent to the following titles within the affected accounts: Chief of Anesthesia, Director of Biomedical / Clinical Engineering, Health Care Administrator / Risk Manager

Root Cause

Under Investigation by firm

Distribution Pattern

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.

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.

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