CLASS III Device recall · Reported 20 Aug 2014 · FDA Enforcement Report

Radiomat M+ NIF ; Radiomat SG NIF recalled by AGFA Healthcare

Agfa Healthcare is recalling Radiomat M+ NIF ; Radiomat SG NIF, distributed nationwide in the US. The recall was initiated on 16 Jul 2014 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesLot Batch No. 79350052, 79380052, 79390074, 79400066, 79410063

Quantity recalled2617

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-2178-2014
FDA event ID: 68844
Recalling firm: Agfa Healthcare, Greenville, SC
Classification: Class III
Status: Terminated
Recall initiated: 16 Jul 2014
FDA classified: 9 Aug 2014
Reported: 20 Aug 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Imaging Equipment

Timeline

16 Jul 2014	Recall initiated by company
9 Aug 2014	Classified by FDA	+24 days
20 Aug 2014	Published in enforcement report	+11 days

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

Reason for recall

Some sheets of the medical screen film are fogged.

Product as listed by the FDA

Radiomat M+ NIF 14 x 17; Radiomat SG 14 x 17 NIF; RX-B 8 x 10 in./IBF-004355; Radiomat B+ NIF 14 x 17; Radiomat B+ NIF 8 x 10; Radiomat B+ NIF 9 1/2 x 9 1/2; CX Ultra UV-G Plus NIF 11 x 14; Radiomat G Plus 14 x 17 NIF Product Usage: Radiographic film is a device that consists of a thin sheet of radiotransparent material coated on one or both sides of the film, with a radiotransparent material coated on one or both sides of the film, with a photographic emulsion intended to record images during diagnostic radiologic procedures.

Where it was distributed

Worldwide Distribution and US Nationwide in the states of AL, AZ, CA, FL, IL, LA, MI, MN, MS, NE, NH, NJ, NC and country of Canada

Nationwide Alabama Arizona California Florida Illinois Louisiana Michigan Minnesota Mississippi North Carolina Nebraska New Hampshire New Jersey

Questions about this recall

Why was it recalled?

Some sheets of the medical screen film are fogged.

Which lots are affected?

Lot Batch No. 79350052, 79380052, 79390074, 79400066, 79410063

Where was it sold?

Worldwide Distribution and US Nationwide in the states of AL, AZ, CA, FL, IL, LA, MI, MN, MS, NE, NH, NJ, NC and country of 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 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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