FDA Device recall Z-0313-2021
GE Datex-Ohmeda Aisys CS2 Anesthesia System - Product Usage: is intended to provide general inhalation anesthesia and ventilatory support t…
- FDA Device
- Class II
- ongoing
- Published 2020-11-11
On 2020-11-11 the FDA classified a Class II recall of GE Datex-Ohmeda Aisys CS2 Anesthesia System - Product Usage: is intended to provide general inhalation anesthesia and ventilatory support t… 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-0313-2021 |
| 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
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.
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-0313-2021%22
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