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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 86531

7 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
September 17, 2020
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
GE Healthcare, LLC

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

7 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 7

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.

Z-0311-2021
Recall number
Z-0311-2021
Initiated
September 17, 2020
Classification
Class II
Status
Ongoing
Recalling firm
GE Healthcare, LLC
Quantity
2 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Flow sensors could have damaged tubes in the form of small punctures or cuts.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Flow sensors could have damaged tubes in the form of small punctures or cuts.

Code information

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

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

device · product 2 of 7

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.

Z-0312-2021
Recall number
Z-0312-2021
Initiated
September 17, 2020
Classification
Class II
Status
Ongoing
Recalling firm
GE Healthcare, LLC
Quantity
88 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Flow sensors could have damaged tubes in the form of small punctures or cuts.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Flow sensors could have damaged tubes in the form of small punctures or cuts.

Code information

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

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

device · product 3 of 7

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.

Z-0313-2021
Recall number
Z-0313-2021
Initiated
September 17, 2020
Classification
Class II
Status
Ongoing
Recalling firm
GE Healthcare, LLC
Quantity
101 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Flow sensors could have damaged tubes in the form of small punctures or cuts.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Flow sensors could have damaged tubes in the form of small punctures or cuts.

Code information

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

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

device · product 4 of 7

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

Z-0314-2021
Recall number
Z-0314-2021
Initiated
September 17, 2020
Classification
Class II
Status
Ongoing
Recalling firm
GE Healthcare, LLC
Quantity
37 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Flow sensors could have damaged tubes in the form of small punctures or cuts.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Flow sensors could have damaged tubes in the form of small punctures or cuts.

Code information

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

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

device · product 5 of 7

Flow Sensor Service Part, Catalog 2089610-001-S

Z-0315-2021
Recall number
Z-0315-2021
Initiated
September 17, 2020
Classification
Class II
Status
Ongoing
Recalling firm
GE Healthcare, LLC
Quantity
4794 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Flow sensors could have damaged tubes in the form of small punctures or cuts.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Flow sensors could have damaged tubes in the form of small punctures or cuts.

Code information

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)

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

device · product 6 of 7

Flow Sensor Service Part, Catalog 2087640-001-S

Z-0316-2021
Recall number
Z-0316-2021
Initiated
September 17, 2020
Classification
Class II
Status
Ongoing
Recalling firm
GE Healthcare, LLC
Quantity
388

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Flow sensors could have damaged tubes in the form of small punctures or cuts.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Flow sensors could have damaged tubes in the form of small punctures or cuts.

Code information

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)

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

device · product 7 of 7

Flow Sensor Service Part, Catalog 2096513-001-S

Z-0317-2021
Recall number
Z-0317-2021
Initiated
September 17, 2020
Classification
Class II
Status
Ongoing
Recalling firm
GE Healthcare, LLC
Quantity
2 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Flow sensors could have damaged tubes in the form of small punctures or cuts.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Flow sensors could have damaged tubes in the form of small punctures or cuts.

Code information

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)

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