Remote Diagnostic Technologies Ltd. has recalled Tempus LS-Manual Defibrillators (Model 00-3020) because incorrect labels were applied to the devices during servicing. The Tempus LS-Manual is a defibrillator that delivers electric shocks in manual or Pacemaker mode. The affected labels contain the incorrect product name and catalog (CAT) number, which may cause confusion for medical staff. No injuries or incidents have been reported in connection with this issue.
Incorrect labeling on a life-saving medical device can lead to confusion about the device's identity or functionality during an emergency. Although no injuries have been reported, using mislabeled equipment can potentially delay or interfere with critical medical treatment.
Labels applied during servicing contain incorrect product name and CAT number.
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Sources: FDA iRES · Raw API Response
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