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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:03 PM UTC

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