NaviCare Nurse Call/Voalte Nurse Call
FDA Recall Z-1306-2022 · Posted None
Recalling FirmBaxter Healthcare Corporation
Recall StatusOpen, Classified
Product CodeILQ
Date Initiated2022-05-31
Product Quantity283 installations
Reason for Recall
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.
Firm 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
[email protected] within two weeks of receipt of this notice, to confirm
you have received this communication and understand the potential issue."
Persons with questions were directed as follows: "If you have any questions regarding this Urgent Medical Device Correction, please contact Hillrom Technical Support, available twenty-four hours a day, seven days a week, at 1-800-445-3720, option 3, or [email protected]"
Root Cause
Software Design Change
Distribution Pattern
nationwide and Canada
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.