Health product recall

PERSEUS A500 & BABYLEO TN500 (2019-07-30)

Starting date:
July 30, 2019
Posting date:
September 4, 2020
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-73881



Last updated:
2020-09-04

Affected Products

  1. PERSEUS A500
  2. BABYLEO TN500

Reason

In the Wind River Operating System (VxWorks) cybersecurity vulnerabilities were found in the network stack. This means that devices that have an ethernet network connection may be affected. Serial ports (RS 232/MEDIBUS X) are not affected.

Affected products

A. PERSEUS A500

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

MK06000

Companies
Manufacturer

Draegerwerk AG & Co. KGaA

Moislinger Allee 53-55

Lübeck

23542

GERMANY


B. BABYLEO TN500

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

2M60000

Companies
Manufacturer

Draegerwerk AG & Co. KGaA

Moislinger Allee 53-55

Lübeck

23542

GERMANY