Recalls / —
—#155425
Product
Artis zee,x-ray system, angiographic Artis zee is a family of dedicated angiography systems 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 include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Artis zee systems 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: 124081 124061 137662 137668 137391 148001 147871 154827 154847 153197 131101 154035
Why it was recalled
Failures can result due to a component defect on Artis zee systems with an A100 Plus generator of a certain delivery lot and 2-focus Megalix Cat Plus tube unit.
Root cause (FDA determination)
Component design/selection
Action the firm took
CDRH approved the CAP subject to the following conditions: 1. You completed this recall as of May 6, 2017. Report any failures regarding this recall immediately to the District Recall Coordinator. 2. If this recall is expanded to include any additional consignees, models, or end users, any future customer notification letters to be sent must comply with the requirements of 21 CFR 1003.21. This includes, but is not limited to, the prescribed packaging and the statement that you will remedy the defect or bring the product into compliance at no charge.
Recalling firm
- Firm
- Siemens Medical Solutions USA, Inc
- Address
- 40 Liberty Blvd, Malvern, Pennsylvania 19355-1418
Distribution
- Distribution pattern
- Worldwide Distribution - US to AR, KS, MI, IA, IL, WI, MN, WV, OH, and NY
Timeline
- Recall initiated
- 2017-02-03
- Terminated
- 2017-10-24
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #155425. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.