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