—#194130

Product

NaviCare Nurse Call/Voalte Nurse Call

FDA product code: ILQ — System, Communication, Powered
Device class: Class 2
Medical specialty: Physical Medicine
Affected lot / code info: software versions: 3.9.100, 3.9.101,3.9.102, 3.9.200, 3.9.201, and 3.9.300

Why it was recalled

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 (FDA determination)

Software Design Change

Action the firm took

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@sedgwick.com 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 hrccwssupport@hillrom.com"

Recalling firm

Firm: Baxter Healthcare Corporation
Address: 1 Baxter Pkwy, Deerfield, Illinois 60015-4625

Distribution

Distribution pattern: nationwide and Canada

Timeline

Recall initiated: 2022-05-31
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #194130. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.