Reported Oct 3, 2018 · Ongoing
ddR Formula B X-ray System, ddR Formula B Product Usage: X-ray system used for imaging
Swissray Medical
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: Swissray Medical · Hohenrainstrasse 61 · Hochdorf · N/A
Is this the product you have?
- ddR Formula B X-ray System
- ddR Formula B Product UsageX-ray system used for imaging
- Lot codes and dates
- Serial Numbers within U.S.A commerce - 1302002, 1302003, 1302005, 1302009, 1302011, 1402001, 1402002, 1402006, 1402007, 1402008, 1402009, 1402011, 1402012, 1402015, 1502001, 1502002, 1502004, 1502005, 1502006, 1502007, 1602001, 1602002, 1602003, 1602005, 1602006, 1602007 & 1602008 Serial Numbers Outside of U.S.A commerce - 1402005, 1402017, 1502009, 1502010, 1502011, 1302004, 1302006, 1302007, 1302008, 1302010, 1402003, 1402004, 1402010, 1402013, 1402014, 1402016, 1502008, 1602004, 1702001, 1702002, 1702003 & 1702004
- Amount recalled
- 26 units
Where it was sold
- Nationwide
Why it was recalled
Possible injury due to movement of the arm, calibration loss and communication loss.
This product could cause temporary or reversible health problems — stop using it.
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