Public recall detail

CS 1200 and CS 1500 Intraoral Camera

2025-02-25

medium
Recall Safety notice
Quick summary

Quick summary: CS 1200 and CS 1500 Intraoral Camera. Date: 2025-02-25.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: CS 1200 and CS 1500 Intraoral Camera. Date: 2025-02-25.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandCarestream Dental, LLC
ProductCS 1200 and CS 1500 Intraoral Camera
IssueMedical devices - Unauthorised device
Recall classType II
IdentificationRA-76987

Affected products

ProductCS 1500 Intraoral Camera
LotAll lots.
Model6559819
Serial numberAll lots.
DescriptionCS 1500 Intraoral Camera
ProductCS 1200 Intraoral Camera
LotAll lots.
Model6559991
Serial numberAll lots.
DescriptionCS 1200 Intraoral Camera

Issue

Health Canada has determined that Carestream Dental LLC misclassified the CS 1200 and CS 1500 intraoral cameras as Class I medical devices. It has now been correctly identified as belonging to Class II. Recall start date: February 6, 2025

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - General and plastic surgery
CompaniesCarestream Dental, LLC 3625 Cumberland Boulevard, Atlanta, Georgia, United States, 30339
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-76987
Background{}
CompaniesCarestream Dental, LLC 3625 Cumberland Boulevard, Atlanta, Georgia, United States, 30339
AudiencesHealthcare
Source updated2025-02-25

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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