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U.S. Department of Health and Human Services

Class 2 Device Recall NaviCare Nurse Call/ Voalte Nurse Call System

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  Class 2 Device Recall NaviCare Nurse Call/ Voalte Nurse Call System see related information
Date Initiated by Firm May 31, 2022
Create Date June 30, 2022
Recall Status1 Open3, Classified
Recall Number Z-1306-2022
Recall Event ID 90322
Product Classification System, communication, powered - Product Code ILQ
Product NaviCare Nurse Call/Voalte Nurse Call
Code Information software versions: 3.9.100, 3.9.101,3.9.102, 3.9.200, 3.9.201, and 3.9.300
Recalling Firm/
Manufacturer		 Baxter Healthcare Corporation
1 Baxter Pkwy
Deerfield IL 60015-4625
For Additional Information Contact Center for One Baxter
800-422-9837
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 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 in Commerce 283 installations
Distribution nationwide and Canada
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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