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Recall Observatory FDA recall evidence

Device product

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

Z-1094-2022

April 13, 2022

Class II

Product summary

Firm
Baxter Healthcare Corporation
Event
Event 89961
Status
Terminated
Classification
Class II
Quantity
1414 units
Official record key
device-enforcement:Z-1094-2022

Official wording

Reason: Firm discovered a firmware memory leak with a supplier-manufactured component.

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

Distribution pattern: US Distribution to states of: NC and VA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Firm discovered a firmware memory leak with a supplier-manufactured component.