CLASS II Device recall · Reported 1 Sep 2021 · FDA Enforcement Report
Echelon Oval MRI System recalled by Hitachi Healthcare Americas
Hitachi Healthcare Americas is recalling Echelon Oval MRI System, distributed nationwide in the US. The recall was initiated on 29 Jul 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2338-2021
- FDA event ID
- 88452
- Recalling firm
- Hitachi Healthcare Americas, Twinsburg, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 29 Jul 2021
- FDA classified
- 24 Aug 2021
- Reported
- 1 Sep 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Device type
- Imaging Equipment
Timeline
| 29 Jul 2021 | Recall initiated by company | |
| 24 Aug 2021 | Classified by FDA | +26 days |
| 1 Sep 2021 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
There was no label on the pad packaging or notification in the user manual that the table pads contained dry natural rubber which is required by the Code of Federal Regulations section 21CFR801.437.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
ECHELON Oval MRI System
Where it was distributed
Worldwide distribution - US Nationwide and the countries of Mexico and Brazil.
Questions about this recall
Why was it recalled?
There was no label on the pad packaging or notification in the user manual that the table pads contained dry natural rubber which is required by the Code of Federal Regulations section 21CFR801.437.
Which lots are affected?
Y001-Y016, Y051-Y068, Y101-Y169, Y951
Where was it sold?
Worldwide distribution - US Nationwide and the countries of Mexico and Brazil.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 88452This product is part of a recall event; the main page for the event is Oasis MRI System recalled by Hitachi Healthcare Americas.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Oasis MRI System recalled by Hitachi Healthcare Americas | Hitachi Healthcare Americas | Foreign Material | Nationwide | |
| CLASS II | Echelon MRI System recalled by Hitachi Healthcare Americas | Hitachi Healthcare Americas | Foreign Material | Nationwide |
More recalls from Hitachi Healthcare Americas
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Echelon MRI System recalled by Hitachi Healthcare Americas | Hitachi Healthcare Americas | Foreign Material | Nationwide |
| Device | CLASS II | Oasis MRI System recalled by Hitachi Healthcare Americas | Hitachi Healthcare Americas | Foreign Material | Nationwide |
| Device | CLASS II | Model L43K Intraoperative Probe-For the diagnostic ultrasound recalled | Hitachi Healthcare Americas | Sterility | Nationwide |
Other Imaging Equipment recalls
All 2,336| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep Clear recalled | Medline Industries | Packaging Defects | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Ultrasound Breast Pack recalled | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Alphenix Models Infx-8000C Infx-8000F Infx-8000V This device recalled | Canon Medical System USA | Other | Nationwide |
| Device | CLASS II | Merge PACS and Merge OrthoPACS recalled by Merge Healthcare | Merge Healthcare | Labeling Errors | Nationwide |
| Device | CLASS II | Philips Azurion recalled by Philips Medical Systems | Philips Medical Systems Nederl | Potency & Assay |