Recalls / —
—#170426
Product
Sensis Vibe System, Model Number 11007642, with software version VD10B.
- FDA product code
- DQK — Computer, Diagnostic, Programmable
- Device class
- Class 2
- Medical specialty
- Cardiovascular
- 510(k) numbers
- K150493
- Affected lot / code info
- Serial Number 120019
Why it was recalled
A software error may result in a system crash. The system must be restarted before the clinical procedure can be continued. The ablation treatment must be performed with a different system or without the use of the interface.
Root cause (FDA determination)
Software design
Action the firm took
Urgent Medical Device Correction letters were sent to customers on 11/29/18.
Recalling firm
- Firm
- Siemens Medical Solutions USA, Inc
- Address
- 40 Liberty Blvd, Malvern, Pennsylvania 19355-1418
Distribution
- Distribution pattern
- The products were distributed to the following US states: NJ.
Timeline
- Recall initiated
- 2018-11-29
- Terminated
- 2020-05-07
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #170426. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.