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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 81045

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

Open FDA event record

Event summary

Timeline bucket
August 09, 2016
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Swissray Medical

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

ddR Formula B X-ray System, ddR Formula B Product Usage: X-ray system used for imaging

Z-3248-2018
Recall number
Z-3248-2018
Initiated
August 09, 2016
Classification
Class II
Status
Ongoing
Recalling firm
Swissray Medical
Quantity
26 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Possible injury due to movement of the arm, calibration loss and communication loss.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Possible injury due to movement of the arm, calibration loss and communication loss.

Code information

Serial Numbers within U.S.A commerce - 1302002, 1302003, 1302005, 1302009, 1302011, 1402001, 1402002, 1402006, 1402007, 1402008, 1402009, 1402011, 1402012, 1402015, 1502001, 1502002, 1502004, 1502005, 1502006, 1502007, 1602001, 1602002, 1602003, 1602005, 1602006, 1602007 & 1602008 Serial Numbers Outside of U.S.A commerce - 1402005, 1402017, 1502009, 1502010, 1502011, 1302004, 1302006, 1302007, 1302008, 1302010, 1402003, 1402004, 1402010, 1402013, 1402014, 1402016, 1502008, 1602004, 1702001, 1702002, 1702003 & 1702004

Distribution pattern

US Nationwide

Field note

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