Device 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
Z-0402-2022
Product summary
- Firm
- Hill-Rom Inc.
- Event
- Event 88909
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,050 units
- Official record key
device-enforcement:Z-0402-2022
Official wording
Reason: An unrecoverable error may occur where a component will fail to complete the reboot cycle, become non-functional and must be replaced.
Code information: All software versions 3.5.400 and above: a. Part Number 3.6, UDI 00887761001541; Part Number 3.7, UDI 00887761021198; Part Number 3.9, UDI 00887761985209 b. Part Number 4.0, UDI 00887761995079
Distribution pattern: Worldwide distribution - US Nationwide.
Derived failure modes
-
Unknown
An unrecoverable error may occur where a component will fail to complete the reboot cycle, become non-functional and must be replaced.