FDA Device recall Z-0311-2021
Aestiva/5 MRI Anesthesia System - Product Usage: The Aestiva/5 MRI Anesthesia System provides the functional feature set offered by the con…
- FDA Device
- Class II
- ongoing
- Published 2020-11-11
On 2020-11-11 the FDA classified a Class II recall of Aestiva/5 MRI Anesthesia System - Product Usage: The Aestiva/5 MRI Anesthesia System provides the functional feature set offered by the con… by Ge Healthcare, citing flow sensors could have damaged tubes in the form of small punctures or cuts.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0311-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2020-09-17 |
| Published | 2020-11-11 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Ge Healthcare |
| Distribution | 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 |
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.
Reason
Flow sensors could have damaged tubes in the form of small punctures or cuts.
Identifiers
| code_info | Devices with installed flow sensors with etched manufacturing date of 2020-08 (August 2020) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0311-2021%22
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