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U.S. Department of Health and Human Services

Class 2 Device Recall Voalte Nurse Call

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 Class 2 Device Recall Voalte Nurse Callsee related information
Date Initiated by FirmOctober 14, 2021
Create DateDecember 20, 2021
Recall Status1 Terminated 3 on August 16, 2024
Recall NumberZ-0402-2022
Recall Event ID 88909
Product Classification System, communication, powered - Product Code ILQ
ProductThese 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
Code Information 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
FEI Number 2027454
Recalling Firm/
Manufacturer		 Hill-Rom Inc.
1225 Crescent Grn Ste 300
Cary NC 27518-8119
For Additional Information ContactHoward Karesh
312-237-6188
Manufacturer Reason
for Recall		An unrecoverable error may occur where a component will fail to complete the reboot cycle, become non-functional and must be replaced.
FDA Determined
Cause 2		Under Investigation by firm
ActionThe 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 in Commerce1,050 units
DistributionWorldwide distribution - US Nationwide.
Total Product Life CycleTPLC 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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