FDA Medical Device Recalls (openFDA)
Baxter Healthcare Corporation: NaviCare Nurse Call/Voalte Nurse Call
- Recall number
- Z-1306-2022
- Recalling firm
- Baxter Healthcare Corporation
- Product
- NaviCare Nurse Call/Voalte Nurse Call
- Status
- Open, Classified
- Initiated
- 2022-05-31
- Posted
- not on file
- Terminated
- not on file
- Reason
- An issue has been identified with Phillips (Emergin) and Longleaf non relay (Connexall, Vocera, Cerner) wireless integrations used with NaviCare/Voalte Nurse Call, software versions 3.9.100 through 3.9.300. Calls placed from a push button call device, such as a push button switch, call cord, or from the push buttons on a room audio station, will be canceled on the nurse call system when the call is answered at the wireless phone, regardless of the call priority.
- Root cause
- Software Design Change
- Action
- The firm disseminated an Urgent Medical Device Correction Notice beginning on 05/31/2022 by letter. The letter described the problem and requested the following actions be taken by the customer: "Identify if your Nurse Call System utilizes one of the impacted wireless integrations identified. If so, please share the information with potential users in your organization. Hillrom recommends reviewing the wireless system settings with your wireless provider to determine if there are configurable options for call acceptance only. Complete the enclosed response form and return to hillromCARY021@sedgwick.com within two weeks of receipt of this notice, to confirm you have received this communication and understand the potential issue." Persons with questions were directed as follows: "If you have any questions regarding this Urgent Medical Device Correction, please contact Hillrom Technical Support, available twenty-four hours a day, seven days a week, at 1-800-445-3720, option 3, or hrccwssupport@hillrom.com"
- Quantity
- 283 installations
- Distribution
- nationwide and Canada
- Lot, serial or model codes
- software versions: 3.9.100, 3.9.101,3.9.102, 3.9.200, 3.9.201, and 3.9.300
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- ILQ
- Firm FEI
- 1417572
- Firm city
- Deerfield
- Firm state
- IL
- 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