GE Healthcare Recalls all Giraffe Infant Warmers and Panda iRes Infant Warmers

Voluntary Field Corrective Action Issued for GE Healthcare’s Giraffe and Panda i-Res Infant Warmers

Summary

Company Announcement Date:

June 14, 2019

FDA Publish Date:

June 18, 2019

Product Type:

Medical Devices
General Hospital & Personal Use

Reason for Announcement:

Bedside panels and latch areas on the beds may crack, break or become damaged if the unit is not properly used

Company Name:

GE Healthcare

Brand Name:

GE Healthcare

Product Description:

Infant warmers GE Healthcare’s Giraffe and Panda i-Res Infant Warmers

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Company Announcement

GE Healthcare has issued a Recall for all Giraffe Warmers and Panda iRes Warmers, used by hospitals and clinicians. This voluntary field corrective action is being initiated after GE Healthcare became aware that the bedside panels and latch areas on the beds may crack, break or become damaged if the unit is not properly used, by using the bedside panels to move the warmer instead of using the front handle or the rear maneuvering handle.
In March 2019, GE Healthcare notified all hospital customers of this issue through an Urgent Medical Device Correction notice and is now issuing a supplemental notice to all customers with additional clarifications. These notification letters:

• Instruct users to stop use of any warmer if any portion of the bedside panels or latches is cracked, broken or damaged;
• Provide users with new caution labels showing how to properly move the warmer, labels instructing users to make sure bedside panels are latched and secure after each use of the bedside panels, and instructional posters that include pictures of broken and unbroken latches showing how to check the walls for any damage; and
• Equip users with a manual addendum that provides additional clarity on the proper use of the front handle to move the warmer.

As part of this voluntary field corrective action, GE Healthcare will replace all cracked or damaged bedside panels or latches for the Giraffe and Panda warmers and provide the additional safety labels and posters listed above at no cost to customers.
For additional information regarding this field action, or to report complaints or adverse events involving these products to GE Healthcare, please contact GE Healthcare’s Customer Service line (24 hours a day, 7 days a week) at 800-437-1171.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report Online
• Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

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Company Contact Information

Consumers:

GE Healthcare’s Customer Service

800-437-1171