Giraffe and Panda Warmers (2014-04-02)

Starting date:

April 2, 2014

Posting date:

May 8, 2014

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-39379

• 
  Reason
• 
  Affected products

Recalled Product

A. Giraffe Warmer

B. Panda Warmer

Reason

There may be a loss of internal communication that manages the user-adjusted Nellcor SPO2 alarm settings of the affected Giraffe and Panda Ires warmer systems with Nellcor SPO2. The alarms may not activate as expected, which can result in false positive or false negative saturation and pulse rate alarm notifications to the caregiver. The patient's oxygen saturation and pulse rate values are accurate as displayed however, the displayed user-set alarm limits may be different than the actual alarm limits used for alarm activation. All other clinical functionality of the warmer is unaffected.

Affected products