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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 88452

3 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
July 29, 2021
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Hitachi Healthcare Americas Corporation

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

3 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 3

ECHELON MRI System

Z-2337-2021
Recall number
Z-2337-2021
Initiated
July 29, 2021
Classification
Class II
Status
Terminated
Quantity
472 (US); 10 (OUS) total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Vendor change control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

V001-V070, V952

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Mexico and Brazil.

device · product 2 of 3

ECHELON Oval MRI System

Z-2338-2021
Recall number
Z-2338-2021
Initiated
July 29, 2021
Classification
Class II
Status
Terminated
Quantity
472 (US); 10 (OUS) Total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Vendor change control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Mexico and Brazil.

device · product 3 of 3

OASIS MRI System

Z-2339-2021
Recall number
Z-2339-2021
Initiated
July 29, 2021
Classification
Class II
Status
Terminated
Quantity
472 (US); 10 (OUS) Total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Vendor change control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

M001-M329, M951

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Mexico and Brazil.