Summary
The FDA issued a Class II for NaviCare Nurse Call/Voalte Nurse Call by Baxter Healthcare Corporation. Reason: An issue has been identified with Phillips (Emergin) and Longleaf non relay (Connexall, Vocera, Cerner) wireless integrations used with NaviCare/Voalt.
Details
Source
Device Recall
External ID
Z-1306-2022
Action Date
2022-07-06
Status
Ongoing
Category
device
Product Description
NaviCare Nurse Call/Voalte Nurse Call
Lot/Code Info: software versions: 3.9.100, 3.9.101,3.9.102, 3.9.200, 3.9.201, and 3.9.300
Quantity Affected: 283 installations
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.
Distribution
nationwide and Canada
Type: Voluntary: Firm initiated
Recall Initiated: 2022-05-31
Company
Deerfield, IL
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 114 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Baxter Healthcare Corporation has 310 FDA actions in our database, including 286 recalls and 24 clearances.
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 (Baxter Healthcare Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Baxter Healthcare Corporation have FDA actions?
Baxter Healthcare Corporation has 310 FDA actions in our database, including 286 recalls and 24 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1306-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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