Recalls / —
—#168865
Product
ARTIS zee biplane systems with Material 10094141- a Angiographic x-ray system Product Usage: Artis zee is a dedicated angiography system developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the Artis zee includes cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Artis zee can also support the acquisition of position triggered imaging for spatial data synthesis.
- FDA product code
- IZI — System, X-Ray, Angiographic
- Device class
- Class 2
- Medical specialty
- Radiology
- 510(k) numbers
- K073290
- Affected lot / code info
- Serial Numbers: Serial 155122 155149 155151 155105 155148 154671 155126 155131 155132 155119 155121 155118 155147
Why it was recalled
Vibrations of the C-arm of the plane B may result in reduced image quality caused by the screw connection to the C-arm in the ceiling support
Root cause (FDA determination)
Device Design
Action the firm took
Siemens issued on 10/19/18 an Urgent Medial Devoce Correction notification to via AX033/18/S advising users of the problem, health risk, steps to be taken. Siemens has initiated screw connection exchange of the ceiling bearing via Update Instruction AXOSS/17 /S.
Recalling firm
- Firm
- Siemens Medical Solutions USA, Inc
- Address
- 40 Liberty Blvd, Malvern, Pennsylvania 19355-1418
Distribution
- Distribution pattern
- US Nationwide Distribution
Timeline
- Recall initiated
- 2018-10-19
- Terminated
- 2020-04-27
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #168865. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.