Tempus LS-Manual Defibrillator Recalled for Incorrect Servicing Labels
Remote Diagnostic Technologies Ltd. is recalling Tempus LS-Manual Defibrillator Model 00-3020 units distributed in eight U.S. states. The devices were labeled incorrectly during servicing with wrong product name and CAT number.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: FDA Class III medical device recall involving labeling errors (incorrect product name and CAT number applied during servicing). No injuries, deaths, or functional device defects are reported. The issue is documentation and identification-related rather than a functional or safety hazard.
Plain-English summary
Remote Diagnostic Technologies Ltd. is recalling certain Tempus LS-Manual Defibrillator Model 00-3020 units. The Tempus LS-Manual is a defibrillator that can deliver a shock in manual or Pacemaker mode. The recall was initiated because incorrect labels were applied to the devices during servicing. These labels contain the incorrect product name and CAT number.
The affected devices were distributed nationwide in the states of Alabama, California, Florida, Missouri, New York, Ohio, Texas, and Virginia. Units can be identified by model number 00-3020 and the specific serial numbers listed in the recall notice.
Customers who have received a recalled device with incorrect labels should contact Remote Diagnostic Technologies Ltd. for information on obtaining corrected labels or device replacement.
The recalled product
- 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
- Manufacturer
- Remote Diagnostic Technologies Ltd.
- Category
- Medical Device — Defibrillator
- Hazard
Distribution
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