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