Z-1173-2021 Class II Terminated
FDA device recall Z-1173-2021 was initiated by Siemens Medical Solutions USA, Inc on January 27, 2021 and is designated Class II. Reason for recall: System may sporadically freeze (lock-up) during operation or while being in an idle state, no longer possible to interact with the system The recall status is terminated (terminated October 25, 2021). Affected quantity: 37 US.
Recall Details
- Product Type
- Devices
- Report Date
- March 10, 2021
- Initiation Date
- January 27, 2021
- Termination Date
- October 25, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 37 US
Product Description
Sensis / Sensis Vibe systems with software version VD12 and equipped with HP Flex Pro-C PC. Diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies Model Numbers: Sensis Vibe Hemo 11007641 Sensis Vibe Combo 11007642 Sensis 10764561 Postprocessing Workstation 6648161 SIS Server 6648153
Reason for Recall
System may sporadically freeze (lock-up) during operation or while being in an idle state, no longer possible to interact with the system
Distribution Pattern
US Nationwide distribution in the states of AK, AR, CA, GU, IA, IL, MI, MO, NC, NE, OR, PA, PA, PR, SD, TN, TX, WA.
Code Information
Software version VD12 and equipped with HP Flex Pro-C PC Serial Numbers: 10704 18900 18901 103008 103014 103019 103022 103039 103040 103042 103047 103048 103053 103079 103080 103082 103086 103088 103089 103090 103115 103116 103117 103119 103123 103124 103130 103131 103137 103144 103145 103148 103152 103160 103170 103171 123004