These are communication systems, labeled as: a. NaviCare Nurse Call, Part Numbers: 3.6, 3.7, 3.9 b. Voalte Nurse Call
Summary
The FDA issued a Class II for These are communication systems, labeled as: a. NaviCare Nurse Call, Part Numbe by Hill-Rom Inc.. Reason: An unrecoverable error may occur where a component will fail to complete the reboot cycle, become non-functional and must be replaced..
Details
Source
Device Recall
External ID
Z-0402-2022
Action Date
2021-12-29
Status
Terminated
Category
device
Product Description
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
Lot/Code Info: 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
Quantity Affected: 1,050 units
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.
Distribution
Worldwide distribution - US Nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-10-14
Company
Cary, NC
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 113 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Hill-Rom Inc. has 10 FDA actions in our database, including 10 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Hill-Rom Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Hill-Rom Inc. have FDA actions?
Hill-Rom Inc. has 10 FDA actions in our database, including 10 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0402-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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