The Recall Desk
HighFDA (Devices)·Z-2338-2021·Announced 2021-09-01

MRI System Table Pads Missing Required Natural Rubber Allergen Label

Table pads in Hitachi's ECHELON Oval MRI System contain natural rubber but lack required labeling on packaging and in user manuals. Federal regulations under 21 CFR 801.437 mandate disclosure of this material.

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: This is a Class II FDA recall for missing labeling of natural rubber in medical device table pads. The rubric identifies allergen mislabeling on common allergens as a Score 3 (High) hazard. No illnesses or injuries have been reported.

Plain-English summary

Hitachi Healthcare Americas Corporation is recalling the ECHELON Oval MRI System table pads because they contain dry natural rubber without appropriate labeling. Federal regulations under 21 CFR 801.437 require that products containing natural rubber must be labeled on the packaging and in user documentation.

The recall affects 472 units distributed in the United States and 10 units distributed internationally in Mexico and Brazil. The affected products are identified by the following serial code designations: Y001-Y016, Y051-Y068, Y101-Y169, and Y951.

The U.S. Food and Drug Administration has classified this recall as Class II.

The recalled product

Product
ECHELON Oval MRI System
Manufacturer
Hitachi Healthcare Americas Corporation
Category
Medical Device — Medical Imaging Equipment
Hazard
  • allergen-natural-rubber
  • missing-label

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 (4)

  • Y001-Y016
  • Y051-Y068
  • Y101-Y169
  • Y951

Distribution

Distributed nationwide across the United States.

Related recalls

Same category