CLASS II ONGOING Device recall · Reported 28 Nov 2018 · FDA Enforcement Report

NOVA FA DR System recalled by Sedecal

Sedecal is recalling Sedecal NOVA FA DR System. The recall was initiated on 18 Jul 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial Numbers 07360816 through 17291024

Quantity recalled145 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0488-2019
FDA event ID: 81377
Recalling firm: Sedecal, Algete, N/A
Classification: Class II
Status: Ongoing
Recall initiated: 18 Jul 2018
FDA classified: 20 Nov 2018
Reported: 28 Nov 2018
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Lead & Heavy Metals
Device type: Imaging Equipment

Timeline

18 Jul 2018	Recall initiated by company
20 Nov 2018	Classified by FDA	+125 days
28 Nov 2018	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.

Product as listed by the FDA

Sedecal NOVA FA DR System. for diagnostic radiography.

Where it was distributed

US and Canada

Questions about this recall

Is NOVA FA DR System recalled?

Yes. Sedecal recalled NOVA FA DR System on 18 Jul 2018. The recall is Class II and its status is Ongoing. Recall number Z-0488-2019.

Why was it recalled?

Which lots are affected?

Serial Numbers 07360816 through 17291024

Where was it sold?

US and Canada

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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