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

Recall Z-2143-2014 — Ultra-speed Dental Film, Catalog Number/REF 834 8658, KODAK and Carestream DENTAL labels --- Carestream Health Inc.

U.S. FDA — Device Enforcement · United States · 2014-07-02 · Class III

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2143-2014
Date of alert
2014-07-02
Country / jurisdiction
United States
Risk level
Class III
Risk type
recall
Brand
Carestream Health Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
33301201
Reported risk: The Indicator Dot on the film packet's outer printed paper labeling was incorrectly positioned relative to the location of the raised dot on the dental intraoral film. This may cause confusion for the dental practitioner. If the processed film is placed on the view box by referencing the film's raised dot, the image orientation will be rotated 180 degrees.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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