Health product recall

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