FDA · Medical device recall

Aestiva/5 MRI Anesthesia System… and 6 more products

Nov. 11, 2020 Class II

Date: Nov. 11, 2020
Risk class: Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)
Status: Ongoing
Filed by: GE Healthcare, LLC
Reason: Flow sensors could have damaged tubes in the form of small punctures or cuts.
Distribution pattern: U.S. states where product was distributed - AL, AR, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, MT, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI Foreign countries impacted - Australia, Canada, Czech Republic, Estonia, France, Germany, India, Indonesia, Israel, Italy, Kuwait, Latvia, Macedonia, Madagascar, Malaysia, Nicaragua, Panama, Qatar, Russia, Singapore, Slovenia, Spain, Thailand, Ukraine, United Kingdom

7 products in this recall

Aestiva/5 MRI Anesthesia System…

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 3.0 Tesla shielded MRI devices in a field strength that did not exceed 300 gauss.
Quantity: 2 devices
Codes and lots: Devices with installed flow sensors with etched manufacturing date of 2020-08 (August 2020)
Recall started: Sept. 17, 2020
Device type: Gas-Machine, Anesthesia
Root cause (FDA): Process control
What the company told customers: GE will issue an Urgent Medical Device Correction letter to customers with affected flow sensors. This letter will inform the customer of the issue and provide safety instructions, including to inspect all inventory of Flow Sensors. GE Healthcare will replace the Flow Sensors indicated on returned customer response forms, if applicable. In the U.S., this letter will be sent by a traceable means. The letter will be sent to the following titles within the affected accounts: Chief of Anesthesia, Director of Biomedical / Clinical Engineering, and Health Care Administrator / Risk Manager. GE Healthcare will document customer acknowledgment of the receipt and understanding of the letter, and the replacement of Flow Sensors, if needed.
Recall number: Z-0311-2021

GE Datex-Ohmeda Avance CS2 Anesthesia System…

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.
Quantity: 88 devices
Codes and lots: Devices with installed flow sensors with etched manufacturing date of 2020-08 (August 2020)
Recall started: Sept. 17, 2020
Device type: Gas-Machine, Anesthesia
Root cause (FDA): Process control
What the company told customers: GE will issue an Urgent Medical Device Correction letter to customers with affected flow sensors. This letter will inform the customer of the issue and provide safety instructions, including to inspect all inventory of Flow Sensors. GE Healthcare will replace the Flow Sensors indicated on returned customer response forms, if applicable. In the U.S., this letter will be sent by a traceable means. The letter will be sent to the following titles within the affected accounts: Chief of Anesthesia, Director of Biomedical / Clinical Engineering, and Health Care Administrator / Risk Manager. GE Healthcare will document customer acknowledgment of the receipt and understanding of the letter, and the replacement of Flow Sensors, if needed.
Recall number: Z-0312-2021

GE Datex-Ohmeda Aisys CS2 Anesthesia System…

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.
Quantity: 101 devices
Codes and lots: Devices with installed flow sensors with etched manufacturing date of 2020-08 (August 2020)
Recall started: Sept. 17, 2020
Device type: Gas-Machine, Anesthesia
Root cause (FDA): Process control
What the company told customers: GE will issue an Urgent Medical Device Correction letter to customers with affected flow sensors. This letter will inform the customer of the issue and provide safety instructions, including to inspect all inventory of Flow Sensors. GE Healthcare will replace the Flow Sensors indicated on returned customer response forms, if applicable. In the U.S., this letter will be sent by a traceable means. The letter will be sent to the following titles within the affected accounts: Chief of Anesthesia, Director of Biomedical / Clinical Engineering, and Health Care Administrator / Risk Manager. GE Healthcare will document customer acknowledgment of the receipt and understanding of the letter, and the replacement of Flow Sensors, if needed.
Recall number: Z-0313-2021

9100c NXT system…

Product: 9100c NXT system - Product Usage: Device is licensed and distributed outside of the US only.
Quantity: 37 devices
Codes and lots: Devices with installed flow sensors with etched manufacturing date of 2020-08 (August 2020)
Recall started: Sept. 17, 2020
Device type: Gas-Machine, Anesthesia
Root cause (FDA): Process control
What the company told customers: GE will issue an Urgent Medical Device Correction letter to customers with affected flow sensors. This letter will inform the customer of the issue and provide safety instructions, including to inspect all inventory of Flow Sensors. GE Healthcare will replace the Flow Sensors indicated on returned customer response forms, if applicable. In the U.S., this letter will be sent by a traceable means. The letter will be sent to the following titles within the affected accounts: Chief of Anesthesia, Director of Biomedical / Clinical Engineering, and Health Care Administrator / Risk Manager. GE Healthcare will document customer acknowledgment of the receipt and understanding of the letter, and the replacement of Flow Sensors, if needed.
Recall number: Z-0314-2021

Flow Sensor Service Part…

Product: Flow Sensor Service Part, Catalog 2089610-001-S
Quantity: 4794 units
Codes and lots: 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)
Recall started: Sept. 17, 2020
Device type: Gas-Machine, Anesthesia
Root cause (FDA): Process control
What the company told customers: GE will issue an Urgent Medical Device Correction letter to customers with affected flow sensors. This letter will inform the customer of the issue and provide safety instructions, including to inspect all inventory of Flow Sensors. GE Healthcare will replace the Flow Sensors indicated on returned customer response forms, if applicable. In the U.S., this letter will be sent by a traceable means. The letter will be sent to the following titles within the affected accounts: Chief of Anesthesia, Director of Biomedical / Clinical Engineering, and Health Care Administrator / Risk Manager. GE Healthcare will document customer acknowledgment of the receipt and understanding of the letter, and the replacement of Flow Sensors, if needed.
Recall number: Z-0315-2021

Flow Sensor Service Part…

Product: Flow Sensor Service Part, Catalog 2087640-001-S
Quantity: 388
Codes and lots: 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)
Recall started: Sept. 17, 2020
Device type: Gas-Machine, Anesthesia
Root cause (FDA): Process control
What the company told customers: GE will issue an Urgent Medical Device Correction letter to customers with affected flow sensors. This letter will inform the customer of the issue and provide safety instructions, including to inspect all inventory of Flow Sensors. GE Healthcare will replace the Flow Sensors indicated on returned customer response forms, if applicable. In the U.S., this letter will be sent by a traceable means. The letter will be sent to the following titles within the affected accounts: Chief of Anesthesia, Director of Biomedical / Clinical Engineering, and Health Care Administrator / Risk Manager. GE Healthcare will document customer acknowledgment of the receipt and understanding of the letter, and the replacement of Flow Sensors, if needed.
Recall number: Z-0316-2021

Flow Sensor Service Part…

Product: Flow Sensor Service Part, Catalog 2096513-001-S
Quantity: 2 units
Codes and lots: 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)
Recall started: Sept. 17, 2020
Device type: Gas-Machine, Anesthesia
Root cause (FDA): Process control
What the company told customers: GE will issue an Urgent Medical Device Correction letter to customers with affected flow sensors. This letter will inform the customer of the issue and provide safety instructions, including to inspect all inventory of Flow Sensors. GE Healthcare will replace the Flow Sensors indicated on returned customer response forms, if applicable. In the U.S., this letter will be sent by a traceable means. The letter will be sent to the following titles within the affected accounts: Chief of Anesthesia, Director of Biomedical / Clinical Engineering, and Health Care Administrator / Risk Manager. GE Healthcare will document customer acknowledgment of the receipt and understanding of the letter, and the replacement of Flow Sensors, if needed.
Recall number: Z-0317-2021

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement reports, recall numbers Z-0311-2021, Z-0312-2021, Z-0313-2021, Z-0314-2021, Z-0315-2021, Z-0316-2021, Z-0317-2021. The agency record governs; check it and the company before acting.

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