Z-0861-2022 Class II Terminated
FDA device recall Z-0861-2022 was initiated by Remote Diagnostic Technologies Ltd. on January 28, 2022 and is designated Class II. Reason for recall: Distribution of Defibrillators that are not approved or cleared for distribution US Market. The recall status is terminated (terminated July 25, 2024). Affected quantity: 2.
Recall Details
- Product Type
- Devices
- Report Date
- April 13, 2022
- Initiation Date
- January 28, 2022
- Termination Date
- July 25, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2
Product Description
Tempus LS, Type DGE1, CAT 00-3010, REF 3.940590, Software version 1.3.5, UDI: (01)07613365001693
Reason for Recall
Distribution of Defibrillators that are not approved or cleared for distribution US Market.
Distribution Pattern
US Nationwide distribution in the states of IL and KS.
Code Information
Device Serial Numbers 7021.002073 and 7021.002074