Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1127-2014 — 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 --- Th

U.S. FDA — Device Enforcement · United States · 2014-01-24 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1127-2014
Date of alert: 2014-01-24
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Carestream Health Inc.
Product category: device
Product type: Devices

Reported risk: Carestream received problem reports relating to apparent early failure of Kodak 2X00 Intraoral X-ray device arms leading to arm breakage.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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