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
Recall
- Recall Number
- Z-0402-2022
- Event Number
- 88909
- Firm
- Hill-Rom Inc.
- FEI Number
- 2027454
- Product Code
- ILQ
- Status
- Terminated
- Root Cause
- Under Investigation by firm
- Initiated
- October 14, 2021
- Terminated
- August 16, 2024
- Address
- 1225 Crescent Grn, Ste 300, Cary, NC, 27518-8119
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
An unrecoverable error may occur where a component will fail to complete the reboot cycle, become non-functional and must be replaced.
The firm disseminated a Medical Device Correction Notice to its consignees on 10/21/2021 by mail. Customer: Please share the information with potential users in your organization. Complete the attached response form and return to [email protected] within one month of receipt of this notice to confirm you have received this communication and understand the potential issue. In the event, this issue should occur please contact Hillrom Technical Support at 1-800-445-3720, option 3 or [email protected] for service and replacement. Hillrom has remediated this issue as part of the next software upgrade to version 4.0.300. Please contact Hillrom to discuss software upgrade. Distributor: Please share this information with your nurse call customer base. Complete the attached response form and return to [email protected] within one month of receipt of this notice to confirm you have received this communication, understand the potential issue and will take action to inform your customer base.
Worldwide distribution - US Nationwide.
1,050 units