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Class 2 Device Recall Voalte Nurse Call |
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Date Initiated by Firm |
October 14, 2021 |
Create Date |
December 20, 2021 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-0402-2022 |
Recall Event ID |
88909 |
Product Classification |
System, communication, powered - Product Code ILQ
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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 |
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
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Recalling Firm/ Manufacturer |
Hill-Rom Inc. 1225 Crescent Grn Ste 300 Cary NC 27518-8119
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For Additional Information Contact |
Howard Karesh 312-237-6188
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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.
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FDA Determined Cause 2 |
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.
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Quantity in Commerce |
1,050 units |
Distribution |
Worldwide distribution - US Nationwide. |
Total Product Life Cycle |
TPLC Device Report
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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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