Chicago X-Ray Systems Recalls IntraOs 70 X-Ray Systems for Labeling Defects
Chicago X-Ray Systems is recalling 1,960 IntraOs 70 intra-oral x-ray systems because they have missing or incomplete labels and user manual information.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is for missing or incomplete labels and manual information, which falls under the rubric criterion for 'documentation issues' and 'packaging-only problems' with no reported injuries.
Plain-English summary
Chicago X-Ray Systems, Inc. is recalling 1,960 units of the Fona Srl IntraOs 70 intra-oral x-ray system. The recall covers units distributed nationwide in the United States and in Latin America.
The recall was initiated because the systems were found to have missing or incomplete system labels as required by 21 CFR 1010.2 and 1010.3. Additionally, the user's manuals were found to have missing or improperly labeled information as required by 21 CFR 1020.30(h).
The source text does not specify instructions for consumers or healthcare providers on how to resolve the labeling issues.
The recalled product
- Product
- Fona Srl IntraOs 70 intra-oral x-ray system IntraOS 70 is an extra oral source X-ray system for dental radiographic examination and diagnosis of diseases of the teeth.
- Manufacturer
- Chicago X-Ray Systems, Inc.
- Category
- Medical Device — Dental X-Ray
- Hazard
- Affected units
- 1,960
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 (1)
- Model IntraOs 70
Distribution
Distributed nationwide across the United States.
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