ECHELON MRI System Recalled for Missing Natural Rubber Allergen Labeling
Hitachi Healthcare Americas is recalling ECHELON MRI System table pads because packaging and user manuals lack required disclosure that the pads contain dry natural rubber, a potential allergen. No illnesses have been reported.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall for allergen mislabeling: natural rubber disclosure is missing from labeling despite federal requirement (21CFR801.437). Natural rubber/latex is a common allergen; no illnesses or injuries reported, making this a risk-of-harm scenario with theoretical hazard.
Plain-English summary
Hitachi Healthcare Americas Corporation is recalling the ECHELON MRI System in the United States, Mexico, and Brazil. The recall affects approximately 472 units in the US and 10 units outside the US (models V001-V070, V952).
The recalled MRI table pads contain dry natural rubber, but there is no label on the pad packaging or notification in the user manual disclosing this material. Federal regulations under 21CFR801.437 require that natural rubber content be properly labeled. The missing disclosure could put individuals with natural rubber or latex allergies at risk of allergic reactions if they come into contact with the pads.
Healthcare facilities and users should consult the manufacturer for instructions on safe handling or product replacement. No illnesses or injuries have been reported in connection with this recall.
The recalled product
- Product
- ECHELON MRI System
- Manufacturer
- Hitachi Healthcare Americas Corporation
- Category
- Medical Device — MRI Equipment
- Hazard
- allergen-latex
- mis-labeling
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 (2)
- V001-V070
- V952
Distribution
Distributed nationwide across the United States.
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