Baxter Healthcare Corporation: Firm discovered a firmware memory leak with a supplier-manufactured component.

Agency Publication Date: May 13, 2022

Affected Products

Product: NaviCare Nurse Call System provides a comprehensive communication and information system that places patient calls, staff calls, and emergency calls.

Internal Part Number: 3.9.; UDI/GTIN: 00887761985209; P2519NNC3A24 model number of impacted RubyTech Switch

Product: Voalte Nurse Call System provides a comprehensive communication and information system that places patient calls, staff calls, and emergency calls.

Internal Part Number: 4.0.; UDI/GTIN: 00887761995079; P2519NNC3A24 model number of impacted RubyTech Switch

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 89961

Status: Resolved

Manufacturer: Baxter Healthcare Corporation

Manufactured In: United States

Units Affected: 2 products (11028 units; 1414 units)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Medium RiskFDA Device