Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Sedecal NOVA FA DR System. for diagnostic radiography. Recalled by Sedecal S.A. Due to A safety problem with installation and maintenance could...

Date: July 18, 2018
Company: Sedecal S.A.
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Sedecal S.A. directly.

Affected Products

Sedecal NOVA FA DR System. for diagnostic radiography.

Quantity: 145 units

Why Was This 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.

Where Was This Sold?

US and Canada

About Sedecal S.A.

Sedecal S.A. has 4 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report