Aisys Anaesthesia Work Stations

Recalling firm

GE Healthcare Limited

Product

Aisys Anaesthesia Work Stations. [Device]. Model: Aisys CS2, Aisys CS2 with Et Control and S/5 Aisys Anesthesia Delivery Systems. Affected: Replaceable parts: 1011-8000-000-S - Gas Mixer Electronic – Assembly. 5700665 - R-FMI34141 GAS MIXER ELECTRONIC

Reason

The manufacturer has become aware that Aisys CS2, Aisys CS2 with Et Control and S/5 Aisys Anesthesia Delivery Systems, containing certain electronic gas mixer assemblies, can automatically transition to Alternate O2 control., In Alternate O2 control, the system delivers 100% O2 to the breathing system enabling continued controlled or manual ventilation and initiates audible and visual alarms ("Set Alt O2 Flow! Agent delivery off!" or "Set Alt O2 flow! Check agent setting!")., When this issue occurs, anesthetic agent delivery will be interrupted and requires clinician intervention. If this...

Classification

Class I

Category

medical device recall

Country

New Zealand

Agency

MEDSAFE

Recall date

2026-09-23

Status

Ongoing

Distribution

New Zealand - Hospital/Pharmacy/Laboratory

Official recall notice from MEDSAFE

Recall details on Nibble Recalls: https://trynibble.app/recalls/8a68e430-7ec9-40ce-9fb2-a76eb1fea427