FDA Device recall Z-1562-2016

GE Healthcare, Aisys and Aisys CS2. Intended to provide general inhalation anesthesia and ventilator support to a wide range of patients (n…

FDA Device
Class II
terminated
Published 2016-05-04

On 2016-05-04 the FDA classified a Class II recall of GE Healthcare, Aisys and Aisys CS2. Intended to provide general inhalation anesthesia and ventilator support to a wide range of patients (n… by Ge Medical Systems, citing the vacuum suction tubing could be kinked within the machine resulting in suction less than the 20 lpm required by ISO 10079-3. This could result in inadequate suction performance….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-1562-2016
Classification	Class II
Status	terminated
Initiated	2016-03-15
Published	2016-05-04
Last updated	2026-09-13 11:54 UTC
Company	Ge Medical Systems
Distribution	AZ, CA, DC, FL, GA, ID, IL, IN, KY, MD, MI, MN, MO, NC, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI

Product

GE Healthcare, Aisys and Aisys CS2. Intended to provide general inhalation anesthesia and ventilator support to a wide range of patients (neonatal, pediatric, and adult).

Reason

The vacuum suction tubing could be kinked within the machine resulting in suction less than the 20 lpm required by ISO 10079-3. This could result in inadequate suction performance to clear the airway and inadequate ventilation of the patient.

Identifiers

code_info	Mfg Lot or Serial # UDI IDENTIFIER APWU00723 not applicable APWU00724 not applicable APWU01988 010084068210229221APW… Mfg Lot or Serial # UDI IDENTIFIER APWU00723 not applicable APWU00724 not applicable APWU01988 010084068210229221APWU0198811150921 APWU01989 010084068210229221APWU0198911150921 APWU01990 010084068210229221APWU0199011150921 APWU01991 010084068210229221APWU0199111150921 APWU01992 010084068210229221APWU0199211150921 APWU01993 010084068210229221APWU0199311150921 APWU01994 010084068210229221APWU0199411150921 APWU01995 010084068210229221APWU0199511150921 APWU01996 010084068210229221APWU0199611150921 APWU01997 010084068210229221APWU0199711150921 APWU00707 not applicable APWU00708 not applicable APWU00709 not applicable APWU00710 not applicable APWU00711 not applicable APWU02166 010084068210229221APWU0216611151014 APWU02170 010084068210229221APWU0217011151014 APWU02171 010084068210229221APWU0217111151014 APWU02172 010084068210229221APWU0217211151014 APWU00712 not applicable APWU00505 not applicable APWU00506 not applicable APWU00507 not applicable APWU00474 not applic

code_info

Mfg Lot or Serial # UDI IDENTIFIER APWU00723 not applicable APWU00724 not applicable APWU01988 010084068210229221APW…

Mfg Lot or Serial # UDI IDENTIFIER APWU00723 not applicable APWU00724 not applicable APWU01988 010084068210229221APWU0198811150921 APWU01989 010084068210229221APWU0198911150921 APWU01990 010084068210229221APWU0199011150921 APWU01991 010084068210229221APWU0199111150921 APWU01992 010084068210229221APWU0199211150921 APWU01993 010084068210229221APWU0199311150921 APWU01994 010084068210229221APWU0199411150921 APWU01995 010084068210229221APWU0199511150921 APWU01996 010084068210229221APWU0199611150921 APWU01997 010084068210229221APWU0199711150921 APWU00707 not applicable APWU00708 not applicable APWU00709 not applicable APWU00710 not applicable APWU00711 not applicable APWU02166 010084068210229221APWU0216611151014 APWU02170 010084068210229221APWU0217011151014 APWU02171 010084068210229221APWU0217111151014 APWU02172 010084068210229221APWU0217211151014 APWU00712 not applicable APWU00505 not applicable APWU00506 not applicable APWU00507 not applicable APWU00474 not applic

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1562-2016%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.