Health product recall

anesthesia machine Sensor malfunction (2021-07-28)

Starting date:
July 28, 2021
Posting date:
September 10, 2021
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-76389

Last updated: 2021-09-10

Affected Products

  • AISYS CARESTATION ANESTHESIA SYSTEM - MAIN UNIT
  • S/5 AESPIRE 7900 SMARTVENT ANESTHESIA SYSTEM - MAIN UNIT
  • AESTIVA/5 MRI SYSTEM
  • S/5 AESPIRE ANESTHESIA MACHINE
  • AESTIVA/5 ANAESTHESIA MACHINE
  • GE DATEX-OHMEDA AVANCE ANESTHESIA SYSTEM
  • AESPIRE VIEW - ANESTHESIA MACHINE
  • AVANCE CS2 - MAIN UNIT
  • AISYS CS2 ANESTHESIA MACHINE MAIN UNIT

Reason

GE healthcare internally identified that a small number of flow sensors built prior to june 2021 could have damaged tubes with small punctures or cuts. This issue could cause leaks resulting in incorrect anesthesia machine tidal volumes, potentially leading to over-delivery of volume to the patient.

Affected products

AISYS CARESTATION ANESTHESIA SYSTEM - MAIN UNIT

Lot or serial number

More than 10 numbers, contact manufacturer

Model or catalog number

1011-9000-000

Companies
Manufacturer
Datex-Ohmeda
3030 Ohmeda Drive
Madison
53707-7550
Wisconsin
UNITED STATES

S/5 AESPIRE 7900 SMARTVENT ANESTHESIA SYSTEM - MAIN UNIT

Lot or serial number

More than 10 numbers, contact manufacturer

Model or catalog number

1009-9012-000

Companies
Manufacturer
Datex-Ohmeda
3030 Ohmeda Drive
Madison
53707-7550
Wisconsin
UNITED STATES

AESTIVA/5 MRI SYSTEM

Lot or serial number

More than 10 numbers, contact manufacturer

Model or catalog number

1006-9310-000

Companies
Manufacturer
Datex-Ohmeda
3030 Ohmeda Drive
Madison
53707-7550
Wisconsin
UNITED STATES

S/5 AESPIRE ANESTHESIA MACHINE

Lot or serial number

More than 10 numbers, contact manufacturer. 

Model or catalog number

1009-9000-000

Companies
Manufacturer
Datex-Ohmeda
3030 Ohmeda Drive
Madison
53707-7550
Wisconsin
UNITED STATES

AESTIVA/5 ANAESTHESIA MACHINE

Lot or serial number

More than 10 numbers, contact manufacturer

Model or catalog number

1006-9305-000
1006-9321-000

Companies
Manufacturer
Datex-Ohmeda
3030 Ohmeda Drive
Madison
53707-7550
Wisconsin
UNITED STATES

GE DATEX-OHMEDA AVANCE ANESTHESIA SYSTEM

Lot or serial number

More than 10 numbers, contact manufacturer

Model or catalog number

1009-9002-000

Companies
Manufacturer
Datex-Ohmeda
3030 Ohmeda Drive
Madison
53707-7550
Wisconsin
UNITED STATES

AESPIRE VIEW - ANESTHESIA MACHINE

Lot or serial number

More than 10 numbers, contact manufacturer

Model or catalog number

1009-9212-000

Companies
Manufacturer
Datex-Ohmeda
3030 Ohmeda Drive
Madison
53707-7550
Wisconsin
UNITED STATES

AVANCE CS2 - MAIN UNIT

Lot or serial number

More than 10 numbers, contact manufacturer

Model or catalog number

1009-9050-000

Companies
Manufacturer
Datex-Ohmeda
3030 Ohmeda Drive
Madison
53707-7550
Wisconsin
UNITED STATES

AISYS CS2 ANESTHESIA MACHINE MAIN UNIT

Lot or serial number

More than 10 numbers, contact manufacturer

Model or catalog number

1011-9050-000

Companies
Manufacturer
Datex-Ohmeda
3030 Ohmeda Drive
Madison
53707-7550
Wisconsin
UNITED STATES