Voalte Nurse Call recallZ-1094-2022 · Baxter Healthcare Corporation · initiated Apr 13, 2022
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Baxter Healthcare Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Firm discovered a firmware memory leak with a supplier-manufactured component.
FDA root cause category: Software design
What the company is doing
The firm, Hillrom, issued an "Urgent Medical Device Correction Notice", dated 04/13/2022, to impacted consignees via email. The consignee is instructed to identify if they have the impacted product component, Part P2519NNC3A2 and also distribute the notification to personnel as well ensure that the users monitor for system alerts. Notify Hillrom Technical support if there is a loss of connectivity to the nurse call server. Note, error indications will display on multiple user interfaces. Central nurses' stations will state the room(s) is down (disconnected). In patient room(s), graphical audio stations will display clear message stating Station down. Contact Nurse directly . In addition, standard audio stations will have an LED Error state indicator. Complete and return the response form to [email protected]. Hillrom is testing a firmware update for the Power over Ethernet (PoE) switch and anticipates availability in April 2022. Upon receipt of the response form, Hillrom will contact you to schedule an update to your system once firmware is available. If you have any questions regarding this Urgent Medical Device Correction, please contact Hillrom Technical Support at +1 919 854 3361 or [email protected]
Recall details
- Recall number
- Z-1094-2022
- Status
- Terminated
- Initiated by the company
- Apr 13, 2022
- Recalling firm
- Baxter Healthcare Corporation
- Quantity
- 1414 units
- Product code
- ILQ
- Distribution
- US Distribution to states of: NC and VA.
Product description
Voalte Nurse Call System provides a comprehensive communication and information system that places patient calls, staff calls, and emergency calls.
Code information (models, lots, serial numbers)
Internal Part Number: 4.0.; UDI/GTIN: 00887761995079; P2519NNC3A24 model number of impacted RubyTech Switch
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Voalte Nurse Call 4.0Hill-Rom, Inc. · System, communication, powered2 recalls2 deaths405 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 89961).
- Z-1093-2022 · TerminatedNaviCare Nurse Call System provides a comprehensive communication and information system that places patient calls, staff calls, and emergency calls.
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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