Recall Z-0402-2022 ยท ILQ System, Communication, Powered
Hill-Rom Inc.
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
| Date | Oct 14, 2021 |
| Status | Terminated |
| Reason | An unrecoverable error may occur where a component will fail to complete the reboot cycle, become non-functional and must be replaced. |
| Root cause | Under Investigation by firm |
| Action | 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 HillromCARY007@sedgwick.com 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 hrccwssupport@hillrom.com for service and replacement. Hillrom has remediated this issue as part of th |
| Quantity | 1,050 units |
| Distribution | Worldwide distribution - US Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.