Product Safety Recalls

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Product Recall Tracker

Remote Diagnostic Technologies Ltd. Recall 89595

Page Last Updated: April 15, 2022

Description: Tempus LS, Type DGE1, CAT 00-3010, REF 3.940590, Software version 1.3.5, UDI: (01)07613365001693

Remote Diagnostic Technologies Ltd. Recall 89595 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0861-2022
Event ID89595
Event DescriptionTempus LS, Type DGE1, CAT 00-3010, REF 3.940590, Software version 1.3.5, UDI: (01)07613365001693
Product TypeDevices
DistributionUS Nationwide distribution in the states of IL and KS.
Quantity2
Recall ReasonDistribution of Defibrillators that are not approved or cleared for distribution US Market.
Device Classification20220413
Device Code InfoDevice Serial Numbers 7021.002073 and 7021.002074
Center Classification Date20220404
Recall Initiation Date20220128
Recalling FirmRemote Diagnostic Technologies Ltd.
Initial Notification E-Mail
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