Swissray Medical recalls ddR Formula B X-ray System, ddR Formula B Product Usage: X-ray system used for imaging
- Recall date
- August 9, 2016
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-3248-2018
- FDA classification
- Class II
- Brand / firm
- Swissray Medical
- Sold / distributed
- US Nationwide
Why it was recalled
Possible injury due to movement of the arm, calibration loss and communication loss.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
ddR Formula B X-ray System, ddR Formula B Product Usage: X-ray system used for imaging
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