Tempus LS-Manual Defibrillator Model 00-3020 The Tempus LS-Manual is a defibrillator that can deliver a shock in man
Summary
The FDA issued a Class III for Tempus LS-Manual Defibrillator Model 00-3020 The Tempus LS-Manual is a defib by Remote Diagnostic Technologies Ltd.. Reason: Due to incorrect labels applied to devices during servicing. Labels contain the incorrect product name and CAT number..
Details
Source
Device Recall
External ID
Z-0557-2025
Action Date
2024-12-04
Status
Ongoing
Category
device
Product Description
Tempus LS-Manual Defibrillator Model 00-3020 The Tempus LS-Manual is a defibrillator that can deliver a shock in manual or Pacemaker mode
Lot/Code Info: Model Number: 00-3020 UDI-DI code: 07613365002737 Serial Numbers: 7022.000367 7022.000387 7022.000392 7022.000462 7022.000463 7022.000464 7022.000559 7022.000591 7022.000595 7022.000711 7022.000781 7022.000786 7022.00108 7022.001175 7022.001201 7022.00129 7022.001556 7022.001582
Reason for Recall
Due to incorrect labels applied to devices during servicing. Labels contain the incorrect product name and CAT number.
Distribution
U.S. Nationwide distribution in the states of AL, CA, FL, MO, NY, OH, TX and VA.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-10-28
Company
Farnborough
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 162 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 III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
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-0557-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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