CLASS II Device recall · Reported 15 Apr 2015 · FDA Enforcement Report

CS 8100, Catalog # (s): 5303045, 5311129, 5303060, 5303110 Intended recalled

Carestream Health is recalling CS 8100, Catalog # (s): 5303045, 5311129, 5303060, 5303110 Intended, distributed in 46 states. The recall was initiated on 8 Jan 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll serial numbers of affected devices.

Quantity recalled3,110 units (863 domestically & 2,247 internationally)

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-1377-2015
FDA event ID: 70649
Recalling firm: Carestream Health, Rochester, NY
Classification: Class II
Status: Terminated
Recall initiated: 8 Jan 2015
FDA classified: 3 Apr 2015
Reported: 15 Apr 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Imaging Equipment

Timeline

8 Jan 2015	Recall initiated by company
3 Apr 2015	Classified by FDA	+85 days
15 Apr 2015	Published in enforcement report	+12 days

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

Reason for recall

Units device head descended unexpectedly

Product as listed by the FDA

CS 8100, CATALOG # (s): 5303045, 5311129, 5303060, 5303110 Intended to produce complete or segmented tomographic digital panoramic X-ray images to be used at the direction of healthcare professionals of the dento-maxillo-facial region of the human anatomy as diagnostic support for pediatric and adult patient.

Where it was distributed

Worldwide Distribution -- US, including the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NV, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, and WV; and the countries of India and Switzerland.

Alabama Arkansas Arizona California Colorado Connecticut District of Columbia Delaware Florida Georgia Hawaii Iowa Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland Maine

Questions about this recall

Is CS 8100, Catalog # (s): 5303045, 5311129, 5303060, 5303110 Intended recalled?

Yes. Carestream Health recalled CS 8100, Catalog # (s): 5303045, 5311129, 5303060, 5303110 Intended on 8 Jan 2015. The recall is Class II and its status is Terminated. Recall number Z-1377-2015.

Why was it recalled?

Units device head descended unexpectedly

Which lots are affected?

All serial numbers of affected devices.

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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