Recalls / —
—#178955
Product
Siemens ARTIS pheno, Model # 10849000. Interventional Fluoroscopic X-Ray System - Product Usage: Angiography system for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
- FDA product code
- OWB — Interventional Fluoroscopic X-Ray System
- Device class
- Class 2
- Medical specialty
- Radiology
- 510(k) numbers
- K163286
- Affected lot / code info
- Serial Numbers 164231, 164234, 164240, 164241, 164242, 164244
Why it was recalled
The potential exists for system movement to be permanently blocked by an activation of the collision sensor integrated in the cover of the collimator even when no collision has occurred.
Root cause (FDA determination)
Device Design
Action the firm took
Siemens Medical Solutions USA, Inc. sent a Customer Safety Advisory Notice to all affected customers via AX070/19/S on 12/20/2019.
Recalling firm
- Firm
- Siemens Medical Solutions USA, Inc
- Address
- 40 Liberty Blvd, Malvern, Pennsylvania 19355-1418
Distribution
- Distribution pattern
- US Nationwide distribution in the states of FL, IL, IN, MA, PA, VA.
Timeline
- Recall initiated
- 2019-12-20
- Terminated
- 2020-05-01
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #178955. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.