Siemens Sensis Vibe Systems Recalled for Potential System Freezes
Siemens is recalling 37 Sensis Vibe systems in the US because they may sporadically freeze during operation or idle, preventing user interaction.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a system lock-up in a medical device used for diagnostic procedures, which poses a risk of harm or interruption of care, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 37 Sensis / Sensis Vibe systems in the United States. The affected units are equipped with software version VD12 and an HP Flex Pro-C PC. These systems are diagnostic and administrative tools used to support hemodynamic catheterizations and/or electrophysiology studies.
The recall is due to a defect where the system may sporadically freeze (lock-up) during operation or while in an idle state. When this occurs, it is no longer possible to interact with the system. The affected model numbers include Sensis Vibe Hemo 11007641, Sensis Vibe Combo 11007642, Sensis 10764561, Postprocessing Workstation 6648161, and SIS Server 6648153.
The affected units were distributed nationwide in the states of AK, AR, CA, GU, IA, IL, MI, MO, NC, NE, OR, PA, PR, SD, TN, TX, and WA. Specific serial numbers are listed in the agency's recall record. Users should contact Siemens Medical Solutions USA, Inc. for instructions on how to resolve the issue.
The recalled product
- Product
- 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
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Hazard
- Affected units
- 37
Distribution
Related recalls
Same manufacturer · Siemens Medical Solutions USA, Inc
See all →- HighARTIS icono floor Medical Imaging System Detector Movement Loss Recall
FDA (Devices) · 2026-07-08
- HighARTIS Icono Ceiling Model 11328100 Loss of Movement Capability Recall
FDA (Devices) · 2026-07-08
- ModerateARTIS icono biplane medical imaging system detector lift malfunction
FDA (Devices) · 2026-07-08
- ModerateARTIS icono ceiling medical imaging monitor suspension system
FDA (Devices) · 2026-07-08
- HighARTIS pheno systems may display zero dose while dose is applied
FDA (Devices) · 2026-06-10
Same hazard · system lockup
See all →- HighPhilips Affiniti Ultrasound Systems Recalled for Software Lock-Up During Exams
FDA (Devices) · 2021-09-29
- HighPhilips Velara Generator Recall for System Lockup Risk
FDA (Devices) · 2017-02-01
- HighPhilips Recalls Velara Generators Due to Potential System Lockup
FDA (Devices) · 2017-02-01
- ModerateSiemens ACUSON X700 Ultrasound System Recalled for Software Lockup
FDA (Devices) · 2016-05-04
- ModerateGE Healthcare Recalls Innova IGS 630 Biplane Imaging Systems
FDA (Devices) · 2014-02-05