Exact FDA event identifier

Event 70238

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket: January 09, 2015
Product types: Device
Classifications: Class I
Statuses: Terminated
Recalling firm wording: Alltech Medical Systems America Inc

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

1 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 1

Echostar Spica 1.5T MRI system, for magnetic resonance imaging of the body.

Z-1061-2015

Recall number: Z-1061-2015
Initiated: January 09, 2015
Classification: Class I
Status: Terminated
Recalling firm: Alltech Medical Systems America Inc
Quantity: 2 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The MRI system safety feature, which lowers the magnetic field in emergency situations, may not work correctly.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The MRI system safety feature, which lowers the magnetic field in emergency situations, may not work correctly.

Code information

Serial numbers: D-ESP-1001 and D-ESP-1003

Distribution pattern

US Distribution in the state of Maryland.