FDA Device recall Z-2595-2021
Flow sensors kept as stand-alone user replaceable spare parts for the GEHC anethesia machines: 2089610-001 FLOW SENSOR, LEGACY VAR ORF BCG…
- FDA Device
- Class II
- ongoing
- Published 2021-10-06
On 2021-10-06 the FDA classified a Class II recall of Flow sensors kept as stand-alone user replaceable spare parts for the GEHC anethesia machines: 2089610-001 FLOW SENSOR, LEGACY VAR ORF BCG… by Ge Healthcare, citing 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 pote….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2595-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-08-02 |
| Published | 2021-10-06 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Ge Healthcare |
| Distribution | US |
Product
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
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.
Identifiers
| code_info | Flow sensors with date of manufacture prior to 2021-06 etched on body of the flow sensor. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2595-2021%22
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