Aestiva/5 MRI System (2019-07-25)
- Starting date:
- July 25, 2019
- Posting date:
- August 9, 2019
- 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-70663
Last updated: 2019-08-09
Affected Products
A. Aestiva/5 7100
B. Aestiva/5 MRI System
C. S/5 Aespire Anesthesia Machine
D. Aestiva/5 Anesthesia Machine
Reason
Certain Aespire and Aestiva Anesthesia Systems were noted to have a theoretical vulnerability to a cyberattack when connected to the hospital network. An insufficiently secured terminal server may provide an opportunity for a malicious actor that has already penetrated the hospital network to send fraudulent flow sensor correction parameters.
Affected products
A. Aestiva/5 7100
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
1006-9320-000
Companies
- Manufacturer
-
Datex-Ohmeda, Inc.
3030 Ohmeda Drive, P.O. Box 7550
Madison
53707-7550
Wisconsin
UNITED STATES
B. 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, Inc.
3030 Ohmeda Drive, P.O. Box 7550
Madison
53707-7550
Wisconsin
UNITED STATES
C. S/5 Aespire Anesthesia Machine
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
1009-9000-00
Companies
- Manufacturer
-
Datex-Ohmeda, Inc.
3030 Ohmeda Drive, P.O. Box 7550
Madison
53707-7550
Wisconsin
UNITED STATES
D. Aestiva/5 Anesthesia Machine
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
1006-9300-000
1006-9305-000
Companies
- Manufacturer
-
Datex-Ohmeda, Inc.
3030 Ohmeda Drive, P.O. Box 7550
Madison
53707-7550
Wisconsin
UNITED STATES