Health product recall

Giraffe Warmer, Giraffe OmniBed Carestation, Giraffe Incubator Carestation CS1, Panda iRes Warmer (2019-10-02)

Starting date:
October 2, 2019
Posting date:
October 18, 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-71319

Last updated: 2019-10-18

Affected Products

A. Giraffe Warmer
B. Giraffe OmniBed Carestation
C. Giraffe Incubator Carestation CS1
D. Panda iRes Warmer

Reason

During an internal review of manufacturing activities, the manufacturer found an electrical safety test deficiency in some identified devices. The device design provides dual electrical safety protections. However, without performing the appropriate electrical safety test, the device could potentially lead to electric leakage affecting the user. There have been no complaints or injuries reported as a result of this issue.

Affected products

A. Giraffe Warmer

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

M1118179

Companies
Manufacturer

Datex-Ohmeda, Inc.

9900 Innovation Drive

Madison

53326

Wisconsin

UNITED STATES

B. Giraffe OmniBed Carestation

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

2082844-001

Companies
Manufacturer

Datex-Ohmeda, Inc.

9900 Innovation Drive

Madison

53326

Wisconsin

UNITED STATES

C. Giraffe Incubator Carestation CS1

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

2082844-002

Companies
Manufacturer

Datex-Ohmeda, Inc.

9900 Innovation Drive

Madison

53326

Wisconsin

UNITED STATES

D. Panda iRes Warmer

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

M1112198

Companies
Manufacturer

Datex-Ohmeda, Inc.

9900 Innovation Drive

Madison

53326

Wisconsin

UNITED STATES