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
Reported: March 10, 2021 Initiated: January 27, 2021 #Z-1173-2021
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
Details
- Recalling Firm
- Siemens Medical Solutions USA, Inc
- Units Affected
- 37 US
- Distribution
- 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.
- Location
- Malvern, PA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Siemens Medical Solutions USA, Inc. Units affected: 37 US.
Why was this product recalled? ▼
System may sporadically freeze (lock-up) during operation or while being in an idle state, no longer possible to interact with the system
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 10, 2021. Severity: Moderate. Recall number: Z-1173-2021.
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