Recall Z-1094-2022 ยท ILQ System, Communication, Powered
Baxter Healthcare Corporation
Voalte Nurse Call System provides a comprehensive communication and information system that places patient calls, staff calls, and emergency calls.
| Date | Apr 13, 2022 |
| Status | Terminated |
| Reason | Firm discovered a firmware memory leak with a supplier-manufactured component. |
| Root cause | Software design |
| Action | 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 au |
| Quantity | 1414 units |
| Distribution | US Distribution to states of: NC and VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.