🔍 RecallPedia

Infant Warmer System (IWS)

Class I - Dangerous
🏥 Medical Devices Recalled: May 5, 2017 GE Healthcare Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    Medical device listing number: D103053, D103054, D103056, D103057, D183529
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
GE Healthcare, LLC
Reason for Recall:
GE Healthcare has recently become aware of a potential safety issue related to loose screws in the Heater Head of the Infant Warmer System (IWS). Hot screws from the Heater Head of the IWS could fall onto the bed if the Heater Head assembly has been improperly serviced. This situation can be clinically hazardous because thermal injury to a patient could result. Two injuries have been reported as a result of this issue.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

Infant Warmer System (IWS)

Product Codes/Lot Numbers:

Medical device listing number: D103053, D103054, D103056, D103057, D183529

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2323-2017

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Class I - Dangerous

There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-IW (PACS-IW), Centricity Radiology RA600 (RA600), & Centricity Cardiology CA1000 (CA1000) where the service login credentials are able to be identified which could allow a malicious actor with these credentials to access the system and potentially manipulate patient data.

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