Tempus LS, Type DGE1, CAT 00-3010, REF 3.940590, Software version 1.3.5, UDI: (01)07613365001693
Summary
The FDA issued a Class II for Tempus LS, Type DGE1, CAT 00-3010, REF 3.940590, Software version 1.3.5, UDI: (0 by Remote Diagnostic Technologies Ltd.. Reason: Distribution of Defibrillators that are not approved or cleared for distribution US Market..
Details
Source
Device Recall
External ID
Z-0861-2022
Action Date
2022-04-13
Status
Terminated
Category
device
Product Description
Tempus LS, Type DGE1, CAT 00-3010, REF 3.940590, Software version 1.3.5, UDI: (01)07613365001693
Lot/Code Info: Device Serial Numbers 7021.002073 and 7021.002074
Quantity Affected: 2
Reason for Recall
Distribution of Defibrillators that are not approved or cleared for distribution US Market.
Distribution
US Nationwide distribution in the states of IL and KS.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-01-28
Company
Basingstoke
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 149 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Remote Diagnostic Technologies Ltd. has 11 FDA actions in our database, including 11 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 (Remote Diagnostic Technologies Ltd.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Remote Diagnostic Technologies Ltd. have FDA actions?
Remote Diagnostic Technologies Ltd. has 11 FDA actions in our database, including 11 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0861-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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