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.
What this means for you
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
- mis-labeling
Distribution
Distributed nationwide across the United States.
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