Z-1378-2015Class II

CS 8100 3D, CATALOG # (s): 5311162, 5311188. Intended to produce complete or segmented tomographic digital...

Name: Z-1378-2015 CS 8100 3D, CATALOG # (s): 5311162, 5311188. Intended to produce complete or segmented tomographic digital...
Creator: Carestream Health, Inc.
Published: 2015-01-08
License: https://open.fda.gov/license/

Eastman Kodak Company / initiated 2015-01-08 / Terminated / root cause: design

FDA source

Carestream Health, Inc. began a recall of CS 8100 3D, CATALOG # (s): 5311162, 5311188. Intended to produce complete or segmented tomographic digital panoramic X-ray images and three-dimensional digital... on 2015-01-08. FDA classified it as Class II and gives the reason as "Units device head descended unexpectedly". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1378-2015
Classification: Class II
Status: Terminated
Initiated: 2015-01-08
Posted: 2015-04-03
Terminated: 2017-04-20
Recalling firm: Eastman Kodak Company
Product: CS 8100 3D, CATALOG # (s): 5311162, 5311188. Intended to produce complete or segmented tomographic digital panoramic X-ray images and three-dimensional digital X-ray images of the dentomaxillo-facial area to be used at the direction of healthcare professionals as diagnostic support for pediatric and adult patient.
Product code: MUH System, X-Ray, Extraoral Source, Digital
Reason for recall: Units device head descended unexpectedly
Root cause tag: design
FDA root cause: Component design/selection
Action: The firm sent customers "Urgent: Medical Device Recall" letters, dated December 29, 2014. The letter described the problem, as well as, the actions to be taken. A Carestream Health service representative will contact customers to schedule a visit to inspect the affected devices. Questions or concerns should be directed towards the Carestream Customer Care Center in the U.S. at 1-800-328-2910.
Quantity in commerce: 470 units (127 domestically & 343 internationally)
Distribution: 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.
Product codes and lots: All serial numbers of affected devices.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1378-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1377-2015	Class II	Terminated	Voluntary: Firm initiated	2015-04-15	2015-04-03
Z-1378-2015	Class II	Terminated	Voluntary: Firm initiated	2015-04-15	2015-04-03

Product code MUH

K133406Class IICs 8100 3DTrophy / cleared 2014-03-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)