Recall Z-1306-2022 ยท ILQ System, Communication, Powered
Baxter Healthcare Corporation
NaviCare Nurse Call/Voalte Nurse Call
| Date | May 31, 2022 |
| Status | Open, Classified |
| Reason | An issue has been identified with Phillips (Emergin) and Longleaf non relay (Connexall, Vocera, Cerner) wireless integrations used with NaviCare/Voalte Nurse Call, software versions 3.9.100 through 3.9.300. Calls placed from a push button call device, such as a push button switch, call cord, or from the push buttons on a room audio station, will be canceled on the nurse call system when the call is answered at the wireless phone, regardless of the call priority. |
| Root cause | Software Design Change |
| Action | The firm disseminated an Urgent Medical Device Correction Notice beginning on 05/31/2022 by letter. The letter described the problem and requested the following actions be taken by the customer: "Identify if your Nurse Call System utilizes one of the impacted wireless integrations identified. If so, please share the information with potential users in your organization. Hillrom recommends reviewing the wireless system settings with your wireless provider to determine if there are configurable options for call acceptance only. Complete the enclosed response form and return to hillromCARY021@ |
| Quantity | 283 installations |
| Distribution | nationwide and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.