Recall Z-0402-2022— Hill-Rom Inc.
Class II · Terminated
Class II FDA medical device recall by Hill-Rom Inc., initiated 2021-10-14, terminated 2024-08-16. FDA's recall record names no specific 510(k) clearance for this event. 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: An unrecoverable error may occur where a component will fail to complete the reboot cycle, become non-functional and must be replaced..
- Recalling firm
- Hill-Rom Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-10-14
- Terminated
- 2024-08-16
- Firm location
- Cary, NC, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.