Health product recall

Infinity Delta Patient Monitor (2019-02-27)

Starting date:
February 27, 2019
Posting date:
March 28, 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-69422

Affected Products

Infinity Delta Patient Monitor

Reason

In March 2017 affected customers were informed to discontinue use of Delta, Delta XL and Kappa patient monitors running software VF10 with any Scio module or downgrade the patient monitors to the previous software version (VF9.1). Draeger has released software version VF10.1 that corrects this issue.

Affected products

Infinity Delta Patient Monitor

Lot or serial number

5396182958
6008355470
6008535267
6008537461
6008537862
6008539566

Model or catalog number

MS18597

Companies
Manufacturer

Draeger Medical Systems, Inc.

3135 Quarry Road

Telford

18969

Pennsylvania

UNITED STATES