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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 92464

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

Open FDA event record

Event summary

Timeline bucket
May 23, 2023
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
SEDECAL SA

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

wDR 2.2 Mobile Digital Diagnostic X-Ray System

Z-2045-2023
Recall number
Z-2045-2023
Initiated
May 23, 2023
Classification
Class II
Status
Ongoing
Recalling firm
SEDECAL SA
Quantity
1061 units

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software login in issue

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a software login in issue that may prevent the user from logging in.

Code information

Model MobileDiagnost wDR: 1) Model Number 712007, Software versions 2.2.0, 2.2.1, 2.2.2, and 2.2.3 2) Model Number 712006, Software versions 2.2.0, 2.2.1, 2.2.2, and 2.2.3 3) Model Number 712004, Software version 2.1 with Windows 10 Upgrade 4) Model Number 712002, Software version 2.1 with Windows 10 Upgrade

Distribution pattern

Distribution throughout United States including Puerto Rico and US Virgin Islands OUS distribution to Albania, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Botswana, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Curacao, Czech Republic, Dominican Republic, Egypt, Finland, France, Germany, Hungary, Indonesia, Iran, Iraq, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Latvia,Lebanon, Libya, Lithuania, Luxembourg, Malaysia, Malta, Martinique, Mexico, Myanmar, Netherlands, New Zealand, Nigeria, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Suriname, Sweden, Switzerland, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Vietnam, and Zambia