FDA recall Z-0402-2022

Product

These are communication systems, labeled as: a. NaviCare Nurse Call, Part Numbers: 3.6, 3.7, 3.9 b. Voalte Nurse Call, Part Number 4.0 *Product was rebranded from NaviCare to Voalte in 2020

Reason for recall

An unrecoverable error may occur where a component will fail to complete the reboot cycle, become non-functional and must be replaced.

Distribution

Worldwide distribution - US Nationwide.

Key facts

Status

Terminated

Initiation date

2021-10-14

Report date

2021-12-29

Termination date

2024-08-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Cary, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0402-2022