Recall archive / FDA device enforcement
Voalte Nurse Call System provides a comprehensive communication and information system that places patient calls, sta... — FDA record Z-1094-2022
Reported terminated
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Apr 13, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Voalte Nurse Call System provides a comprehensive communication and information system that places patient calls, staff calls, and emergency calls.
- Reason
- Firm discovered a firmware memory leak with a supplier-manufactured component.
- Classification
- Class II
- Recalling firm
- Baxter Healthcare Corporation
- Quantity
- 1414 units
- Agency-reported status
- Terminated
- Source record identifier
- Z-1094-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Internal Part Number: 4.0.; UDI/GTIN: 00887761995079; P2519NNC3A24 model number of impacted RubyTech Switch |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US Distribution to states of: NC and VA.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- May 25, 2022
- Recall initiation date
- Apr 13, 2022
- Center classification date
- May 13, 2022
- Termination date
- Dec 20, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.