Reported Dec 12, 2018 · Terminated
STEPHANIX D2RS Digital Dynamic Remote Systemhttp://cts.fda.gov/division-tracking/images/trash.png Product The D2RS…
Stephanix
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Stephanix · Zone Industrielle Du Bayon · La Ricamarie, N/A · N/A
Is this the product you have?
- STEPHANIX
- D2RS Digital Dynamic Remote Systemhttp//cts.fda.gov/division-tracking/images/trash.png Product The D2RS Digital Dynamic Remote System is indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures. It is also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures. It is intended to replace fluoroscopic images obtained through image intensifier technology. Not intended for mammography applications
- Lot codes and dates
DHJ008DIG010DIH012DIH014DIK022DIK024DIL025DIL030DJK051DJK052DKI032DKI033DKJ047DKK051DKK052DLA001DML062
- Amount recalled
- 17 units
Where it was sold
Why it was recalled
The firm has detected a potential risk using the command. After releasing the command, the movement of the table may continue instead of stopping.
This product could cause temporary or reversible health problems — stop using it.
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