Z-1127-2014Class II

Model Kodak 2100 Intraoral X-Ray System, Catalog Numbers 5303144, 8011579 -- Carestream Health, Inc. 150...

Name: Z-1127-2014 Model Kodak 2100 Intraoral X-Ray System, Catalog Numbers 5303144, 8011579 -- Carestream Health, Inc. 150...
Creator: Carestream Health Inc.
Published: 2014-01-24
License: https://open.fda.gov/license/

Eastman Kodak Company / initiated 2014-01-24 / Terminated / root cause: design

FDA source

Carestream Health Inc. began a recall of Model Kodak 2100 Intraoral X-Ray System, Catalog Numbers 5303144, 8011579 -- Carestream Health, Inc. 150 Verona Street Rochester, NY 14608 -- Made in France --... on 2014-01-24. FDA classified it as Class II and gives the reason as "Carestream received problem reports relating to apparent early failure of Kodak 2X00 Intraoral X-ray device arms leading to arm breakage". 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-1127-2014
Classification: Class II
Status: Terminated
Initiated: 2014-01-24
Posted: 2014-03-04
Terminated: 2015-06-18
Recalling firm: Eastman Kodak Company
Product: Model Kodak 2100 Intraoral X-Ray System, Catalog Numbers 5303144, 8011579 -- Carestream Health, Inc. 150 Verona Street Rochester, NY 14608 -- Made in France -- TROPHY 77435 Marne La Vallee --- COMMON/USUAL NAME: Dental X-Ray Systems -- CLASSIFICATION NAME: Unit, X-Ray, Extraoral with timer --- There are four major components: x-ray tube, x-ray generator, collimator and image receptor. These systems are permanently installed diagnostic dental x-ray systems for generation of x-rays for examination of the teeth, jaw and oral structures.
Product code: EHD Unit, X-Ray, Extraoral With Timer
Reason for recall: Carestream received problem reports relating to apparent early failure of Kodak 2X00 Intraoral X-ray device arms leading to arm breakage.
Root cause tag: design
FDA root cause: Component design/selection
Action: Urgent Medical Device Recall Letters (dated 1/24/2014) were sent to the consignees on 1/24/2014 via Certified Mail, Return Receipt Requested.
Quantity in commerce: Domestic: 347 units (total for both)
Distribution: Worldwide distribution. USA (nationwide) and the country of Canada.
Product codes and lots: Serial Numbers starting with WE, WF, WG, WH, WI, WJ, WK, WL, XA, XB, XC, XD, XE, XF, XG, XH, XI, XJ, XK, XL, YA, YB, YC, YD

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1127-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1127-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-12	2014-03-04
Z-1128-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-12	2014-03-04

Product code EHD

K060292Class IIKodak Models 2100 and 2200Kodak-Trophy / cleared 2006-03-03

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)