Reported Sep 26, 2018 · Ongoing
ddR Formula B X-ray System, Model ddR Formula B 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 · N/A
Is this the product you have?
- ddR Formula B X-ray System, Model ddR Formula B X-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
- Amount recalled
- 27 devices in US
Where it was sold
- Nationwide
Why it was recalled
Potential for bucky (the part that holds the grid and is moveable to position the patient) moving unexpectedly.
This product could cause temporary or reversible health problems — stop using it.
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