Recall Z-2595-2021 ยท BSZ Gas-Machine, Anesthesia
GE Healthcare, LLC
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) 20
| Date | Aug 2, 2021 |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Under Investigation by 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 Ca |
| Quantity | 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'lvo |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K172045 | Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100, Aespire 7100, Aespire 7900, Aespire View, Av Datex-Ohmeda, Inc., Nov 3, 2017 |