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

Carestream Directview Cr recalled by Carestream Health

Carestream Health is recalling Carestream Directview Cr, distributed in North Carolina, New York, Ohio. The recall was initiated on 30 Oct 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSoftware Verions: 1) 5.7.312.27 , 2) 5.7.312.27, 3) 5.7.312.2031

Quantity recalled59 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-0820-2015
FDA event ID: 69703
Recalling firm: Carestream Health, Rochester, NY
Classification: Class II
Status: Terminated
Recall initiated: 30 Oct 2014
FDA classified: 16 Dec 2014
Reported: 24 Dec 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Imaging Equipment

Timeline

30 Oct 2014	Recall initiated by company
16 Dec 2014	Classified by FDA	+47 days
24 Dec 2014	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

Reduced mammographic image quality when attempting to print true size multi-format images

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

CARESTREAM DIRECTVIEW CR Software Generates digital mammographic images that can be used for screening and diagnosis of breast cancer.

Where it was distributed

Worldwide Distribution: US distribution to states of : NY, OH, and NC; and countries of: Argentina, Brazil, China, Chile, Colombia, France, Greece, Hong Kong, India, Japan, Korea, Mexico, Peru, Spain, Taiwan, and Thailand.

North Carolina New York Ohio

Questions about this recall

Is Carestream Directview Cr recalled?

Yes. Carestream Health recalled Carestream Directview Cr on 30 Oct 2014. The recall is Class II and its status is Terminated. Recall number Z-0820-2015.

Why was it recalled?

Reduced mammographic image quality when attempting to print true size multi-format images

Which lots are affected?

Software Verions: 1) 5.7.312.27 , 2) 5.7.312.27, 3) 5.7.312.2031

Where was it sold?

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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