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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 87505

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

Open FDA event record

Event summary

Timeline bucket
December 22, 2020
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
EOS Imaging

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

The EOSedge system may acquire two simultaneous orthogonal planar images for a standing or seated patient at low dose. The scan length is defined by the user and may cover the whole body or a specific area (spine, lower limbs, etc.). EOSedge consists of a gantry and an acquisition workstation. ¿ The gantry contains two orthogonal acquisition units, each of which comprises an X-ray source (high frequency generator + X-ray tube + collimator) and an X-ray detection system (detector + electronics). ¿ The acquisition workstation and its software control the generators and detectors. It is also used to enter patient data, via RIS/HIS or manually, to define acquisition parameters, process images and record images in DICOM 3.0 format. The intended use/indications for use, technological characteristics, and principles of operation of the EOSedge system are described below.

Z-1415-2021
Recall number
Z-1415-2021
Initiated
December 22, 2020
Classification
Class II
Status
Terminated
Recalling firm
EOS Imaging
Quantity
11 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Inadequate images resizing and 2D measurement errors may occur when biplanar acquisition has been performed with patient orientation different from AP (Antero-Posterior).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inadequate images resizing and 2D measurement errors may occur when biplanar acquisition has been performed with patient orientation different from AP (Antero-Posterior).

Code information

Product Reference:03663999000108; Serial Numbers: 8.1912.1008, 8.2001.1010, 8.2001.1011, 8.2002.1012, 8.1907.1005, 8.1909.1006, 8.2005.1014, 8.1905.1004, 8.1911.1007, 8.1912.1009, and 8.2006.1016

Distribution pattern

Distributed nationwide to MN, OH and internationally to Australia, Canada, Germany, Spain, and France