FDA Medical devices recall ·
Tempus LS-Manual Defibrillator Model 00-3020 The Tempus LS-Manual is a… recall
- Recall number
- Z-0557-2025
- Date
- (initiated October 28, 2024)
- Company / brand
- Remote Diagnostic Technologies Ltd.
Farnborough Aerospace Centre, Farnborough, United Kingdom - Category
- Medical devices › Class III
- Classification
- Class III
- Status
- Ongoing
- Hazard tags
- Mislabeling
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Tempus LS-Manual Defibrillator Model 00-3020 The Tempus LS-Manual is a defibrillator that can deliver a shock in manual or Pacemaker mode
Why was it recalled?
Due to incorrect labels applied to devices during servicing. Labels contain the incorrect product name and CAT number.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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
Distribution
U.S. Nationwide distribution in the states of AL, CA, FL, MO, NY, OH, TX and VA.
States: Alabama California Florida Missouri New York Ohio Texas Virginia
What does Class III mean?
Class III means use of or exposure to the product is not likely to cause adverse health consequences (for example, a labeling violation).
Source: FDA (medical devices), recall Z-0557-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.