GE Healthcare, LLC: Flow sensors could have damaged tubes in the form of small punctures or cuts.

Agency Publication Date: October 30, 2020

Affected Products

Product: GE Datex-Ohmeda Aisys CS2 Anesthesia System - Product Usage: is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonatal, pediatric adult). The device is intended for volume or pressure control ventilation.

Devices with installed flow sensors with etched manufacturing date of 2020-08 (August 2020)

Product: 9100c NXT system - Product Usage: Device is licensed and distributed outside of the US only.

Devices with installed flow sensors with etched manufacturing date of 2020-08 (August 2020)

Product: Flow Sensor Service Part, Catalog 2089610-001-S

Devices with installed flow sensors with etched manufacturing date of 2020-08 (August 2020). This flow sensor is compatible with the following device models: Aespire 7100/11, Aespire 7900, Aespire View, Aestiva 7100, Aestiva 7900, Aestiva MRI, Aisys, Aisys CS2, Avance, Avance CS2, Amingo (OUS), and 9100c NXT (OUS)

Product: Flow Sensor Service Part, Catalog 2087640-001-S

Product: Flow Sensor Service Part, Catalog 2096513-001-S

Product: Aestiva/5 MRI Anesthesia System - Product Usage: The Aestiva/5 MRI Anesthesia System provides the functional feature set offered by the conventional Aestiva/5 to the clinician with the added ability to be used in the MR environment. Among those standard Aestiva/5 features is the Datex-Ohmeda user interface, all the ventilation parameters of the SmartVent along with the Aestiva breathing circuit. The Aestiva/5 MRI Anesthesia System performed to specifications when tested directly next to 1.5 and

Devices with installed flow sensors with etched manufacturing date of 2020-08 (August 2020)

Product: GE Datex-Ohmeda Avance CS2 Anesthesia System - Product Usage: intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonatal, pediatric, adult). The device is intended for volume or pressure control ventilation.

Devices with installed flow sensors with etched manufacturing date of 2020-08 (August 2020)

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 86531

Status: Active

Manufacturer: GE Healthcare, LLC

Manufactured In: United States

Units Affected: 7 products (2 devices; 88 devices; 101 devices; 37 devices; 4794 units; 388; 2 units)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Affected Products

Devices with installed flow sensors with etched manufacturing date of 2020-08 (August 2020)

Product: 9100c NXT system - Product Usage: Device is licensed and distributed outside of the US only.

Devices with installed flow sensors with etched manufacturing date of 2020-08 (August 2020)

Product: Flow Sensor Service Part, Catalog 2089610-001-S

Product: Flow Sensor Service Part, Catalog 2087640-001-S

Product: Flow Sensor Service Part, Catalog 2096513-001-S

Devices with installed flow sensors with etched manufacturing date of 2020-08 (August 2020)