Reported Nov 28, 2018 · Ongoing

Sedecal NOVA FA DR System. for diagnostic radiography.

Sedecal S.A.

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: Sedecal S.A. · Pol. Industrial Rio De Janiero · Algete, N/A · N/A

Is this the product you have?

  • Sedecal NOVA FA DR System. for diagnostic radiography.
Lot codes and dates
  • Serial Numbers 07360816 through 17291024
Amount recalled
145 units

Why it was recalled

A safety problem with installation and maintenance could lead to the breakage of the two steel cables that support the equipment to its roof anchor. Due to this, the equipment may fall and cause harm to the patient, user, or third parties.

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, 6:47 PM UTC

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