The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1127-2014·Announced 2014-03-12

Carestream Recalls Kodak 2100 Intraoral X-Ray Systems Due to Arm Breakage

Carestream Health is recalling Kodak 2100 Intraoral X-Ray Systems because the device arms may break early. The recall covers 347 units distributed in the US and Canada.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a structural defect in a medical device that could lead to injury, but the source text does not report any specific injuries or illnesses, fitting the High severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Carestream Health, Inc. is recalling the Kodak 2100 Intraoral X-Ray System, Catalog Numbers 5303144 and 8011579. The recall is due to problem reports indicating that the device arms may fail early and break. These systems are permanently installed diagnostic dental x-ray units used to examine teeth, jaw, and oral structures.

The recall covers 347 units distributed in the United States and Canada. Affected units have 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, or YD. The devices were manufactured in France.

Dental practices and consumers should stop using the affected X-ray systems and contact Carestream Health for further instructions on the recall.

The recalled product

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…
Manufacturer
Carestream Health Inc.
Category
Medical Device — Dental X-Ray Systems
Hazard
Affected units
347

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Serial Numbers starting with WE
  • WF
  • WG
  • WH
  • WI
  • WJ
  • WK
  • WL
  • XA
  • XB
  • XC
  • XD
  • XE
  • XF
  • XG
  • XH
  • XI
  • XJ
  • XK
  • XL

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Carestream Health Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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