Z-1094-2022 Class II Terminated
FDA device recall Z-1094-2022 was initiated by Baxter Healthcare Corporation on Apr 13, 2022 and is designated Class II. Reason for recall: Firm discovered a firmware memory leak with a supplier-manufactured component. The recall status is terminated (terminated Dec 20, 2023). Affected quantity: 1414 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 25, 2022
- Initiation Date
- Apr 13, 2022
- Termination Date
- Dec 20, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1414 units
Product Description
Voalte Nurse Call System provides a comprehensive communication and information system that places patient calls, staff calls, and emergency calls.
Reason for Recall
Firm discovered a firmware memory leak with a supplier-manufactured component.
Distribution Pattern
US Distribution to states of: NC and VA.
Code Information
Internal Part Number: 4.0.; UDI/GTIN: 00887761995079; P2519NNC3A24 model number of impacted RubyTech Switch
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1094-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026