Health product recall

Oxylog 3000 (2018-07-24)

Starting date:
July 24, 2018
Posting date:
September 7, 2018
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-67680

Affected products

Oxylog 3000

Reason

A new software is now available with immediate effect for the Oxylog 3000. The new SW version 1.24 resolves a programming defect in the currently available SW version 1.23; The error resulted in the following three user advisory messages no longer being reported:

  • 21 % by vol. Oxygen
  • Self-test O.K.
  • Setting not confirmed

The new SW version 1.24 ensures that all user advisory messages are correctly displayed again. Other Oxylog ventilators, including the Oxylog 3000 plus, do not show this defective response.

Affected products

Oxylog 3000

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

2M86955

Companies
Manufacturer
DRAEGERWERK AG & CO
MOISLINGER ALLEE 53-55
LUBECK
23542
GERMANY