Public recall detail

Iris X80, X90, and PXL Intra-Oral Cameras

2024-12-30

medium
Recall Safety notice
Quick summary

Quick summary: Iris X80, X90, and PXL Intra-Oral Cameras. Date: 2024-12-30.

Recommended action

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

Recall details

Quick summary: Iris X80, X90, and PXL Intra-Oral Cameras. Date: 2024-12-30.

Official details

Affected product details

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

BrandDigital-Doc
ProductIris X80, X90, and PXL Intra-Oral Cameras
IssueMedical devices - Unauthorised device
Recall classType II
IdentificationRA-76776

Affected products

ProductIris X80 Intra-Oral Camera
LotAll lots.
ModelIRIS-X80
Serial numberAll lots.
DescriptionIris X80 Intra-Oral Camera
ProductIris X90 Intra-Oral Camera
LotAll lots.
ModelIRIS-X90
Serial numberAll lots.
DescriptionIris X90 Intra-Oral Camera
ProductPXL Intraoral Camera
LotAll lots.
ModelPXL-1000
Serial numberAll lots.
DescriptionPXL Intraoral Camera

Issue

Class II medical device sold and distributed as a class I medical device. No defects or known safety related issues. Recall Start Date: December 12, 2024

What you should do

  • Affected customers will be notified.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - General and plastic surgery Health products - Medical devices - General hospital and personal use
CompaniesDigital-Doc 4789 Golden Foothill Parkway, El Dorado Hills, California, United States, 95762
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-76776
Background{}
CompaniesDigital-Doc 4789 Golden Foothill Parkway, El Dorado Hills, California, United States, 95762
AudiencesHealthcare
Source updated2024-12-30

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

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