Arial Call Station, Model Numbers CSK200-1069 and CSK200-1069MR, is a wireless nurse call station.
Summary
The FDA issued a Class II for Arial Call Station, Model Numbers CSK200-1069 and CSK200-1069MR, is a wireless n by Securitas Healthcare LLC. Reason: This is a risk that alarms will not be received by the Arial Wireless Nurse Call System and premature depletion of the battery..
Details
Source
Device Recall
External ID
Z-2418-2024
Action Date
2024-07-31
Status
Ongoing
Category
device
Product Description
Arial Call Station, Model Numbers CSK200-1069 and CSK200-1069MR, is a wireless nurse call station.
Lot/Code Info: All units of the Affected Device Models sold between July 26, 2022 and June 5, 2024
Quantity Affected: 77 units
Reason for Recall
This is a risk that alarms will not be received by the Arial Wireless Nurse Call System and premature depletion of the battery.
Distribution
US: FL, CA, AL, ND, MS, WA, MN, TX, OR, WI, MD, NY, NE
Type: Voluntary: Firm initiated
Recall Initiated: 2024-06-20
Company
Lincoln, NE
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 156 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Securitas Healthcare LLC 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 (Securitas Healthcare LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Securitas Healthcare LLC have FDA actions?
Securitas Healthcare LLC 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-2418-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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