FDA Medical Device Recalls (openFDA)
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
- Recall number
- Z-0402-2022
- Recalling firm
- Hill-Rom Inc.
- 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
- Status
- Terminated
- Initiated
- 2021-10-14
- Posted
- not on file
- Terminated
- 2024-08-16
- 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 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 HillromCARY007@sedgwick.com 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.
- Quantity
- 1,050 units
- Distribution
- Worldwide distribution - US Nationwide.
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- ILQ
- Firm FEI
- 2027454
- Firm city
- Cary
- Firm state
- NC
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28