Z-1426-2022 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- July 27, 2022
- Initiation Date
- June 15, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 13 units
Product Description
Sensis Vibe Combo with software version VD12A. A diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac as well as interventional Radiology Model: 11007642
Reason for Recall
Sensis/Sensis Vibe SoftwareVD12A, the ComboBox may encounter a disconnect of its communication during the first patient examination of the day or after a longer period of inactivity to the Sensis Vibe system resulting in no vital signs being available.
Distribution Pattern
US Nationwide Distribution AZ FL KY MI OH PR TX
Code Information
UDI-DI: 04056869010205 Serial Numbers: 123021, 123055, 123056, 123058, 122042, 123004, 122006, 122026, 122029, 123047, 123053, 122011, 121014.