Health product recall

Giraffe, Panda Freestanding, and Panda iRes Warmer (2018-09-10)

Starting date:
September 10, 2018
Posting date:
September 28, 2018
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-67836

Affected products

  1. Giraffe Warmer
  2. Panda Freestanding Warmer
  3. Panda iRes Warmer

Reason

GE Healthcare has found an opportunity to improve performance of its giraffe and panda warmers. This is achieved by switching to a different type of fuse on the power board. Warmers manufactured prior to September 30, 2017 utilized an end cap made of silver. Over time, corrosion/oxidation of the silver end cap may result to non-typical (high) contact resistance between the cap surface and the fuse holder. The new fuses have an end cap made of gold. The gold cap will mitigate corrosion.

Affected products

A. Giraffe Warmer

Lot or serial number

More than 100 numbers, contact manufacturer.

Model or catalog number

M1118179

Companies
Manufacturer

Datex-Ohmeda, Inc

9900 Innovation Drive

Wauwatosa

53226

Wisconsin

UNITED STATES


B. Panda Freestanding Warmer

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

2063568-001

Companies
Manufacturer

Datex-Ohmeda, Inc

9900 Innovation Drive

Wauwatosa

53226

Wisconsin

UNITED STATES


C. Panda iRes Warmer

Lot or serial number

More than 1000 numbers, contact manufacturer.

Model or catalog number

M1112198

Companies
Manufacturer

Datex-Ohmeda, Inc

9900 Innovation Drive

Wauwatosa

53226

Wisconsin

UNITED STATES