CLASS III Device recall · Reported 24 Dec 2014 · FDA Enforcement Report

Radiomat M+ NIF x recalled by AGFA Healthcare

Agfa Healthcare is recalling Radiomat M+ NIF x, distributed nationwide in the US. The recall was initiated on 24 Oct 2014 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesLot 79440009

Quantity recalled142 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-0804-2015
FDA event ID: 69864
Recalling firm: Agfa Healthcare, Greenville, SC
Classification: Class III
Status: Terminated
Recall initiated: 24 Oct 2014
FDA classified: 15 Dec 2014
Reported: 24 Dec 2014
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

24 Oct 2014	Recall initiated by company
15 Dec 2014	Classified by FDA	+52 days
24 Dec 2014	Published in enforcement report	+9 days

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

Reason for recall

Some material of the coating Type CXCPMV3 has potential artifacts showing a small bright thin line when the film is processed.

Product as listed by the FDA

Radiomat M+ NIF 14 x 17, Radiomat M+ NIF 35CM x 43CM, Radiomat M+ NIF 10 x 12, Radiomat M+ NIF 25,4CM x 30,5CM

Where it was distributed

US Nationwide Distribution in the states of: AL, AZ, CA, LA, MI, NE, NH, NJ, NC, VA

Nationwide Alabama Arizona California Louisiana Michigan North Carolina Nebraska New Hampshire New Jersey Virginia

Questions about this recall

Why was it recalled?

Some material of the coating Type CXCPMV3 has potential artifacts showing a small bright thin line when the film is processed.

Which lots are affected?

Lot 79440009

Where was it sold?

US Nationwide Distribution in the states of: AL, AZ, CA, LA, MI, NE, NH, NJ, NC, VA

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 III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

Read the official FDA notice · Source record retrieved 26 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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