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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 67353

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

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Event summary

Timeline bucket
November 15, 2013
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Shimadzu Medical Systems

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

Mobile X-ray System, Model: MUX-100, MUX-100H Product Usage: The device is a mobile X-ray system in order to take general radiography of patients in the hospital who cannnot move and/or of outpatients in emergency

Z-1150-2014
Recall number
Z-1150-2014
Initiated
November 15, 2013
Classification
Class II
Status
Terminated
Recalling firm
Shimadzu Medical Systems
Quantity
56 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Shimadzu Corporation is recalling the Shimadzu Mobile X-ray Sytems (MUX-100 and MUX-100H) because the connecting metal plate which connects the main chassis and the column of MUX-100 may crack.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Shimadzu Corporation is recalling the Shimadzu Mobile X-ray Sytems (MUX-100 and MUX-100H) because the connecting metal plate which connects the main chassis and the column of MUX-100 may crack.

Code information

Serial No. 0262P70907 0262P70908 0262P70909 0262P70910 0262P71001 0262P71002 0262P71003 0262P71004 0262P71005 0262P71006 0162Z01901 0162Z01902 0162Z01903 0162Z01904 0162Z01905 0162Z02002 0162Z02003 0162Z02004 0162Z02005 0162Z02006 0162Z02007 0162Z02008 0162Z02009 0162Z02101 0162Z02108 0162Z02204 0162Z02205 0162Z02302 0162Z02303 0162Z02304 0162Z02305 0162Z02306 0162Z02307 0162Z02308 0162Z02309 0162Z02310 0262Z00205 0262Z00206 0262Z00207 0262Z00208 0262Z00209 0262Z00210 0262Z00307 0262Z00308 0262Z00309 0262Z00310 0262Z00401 0262Z00402 0262Z00403 0262Z00404 0262Z00610 0262Z00701 0262Z00702 0262Z00703 0262Z00704 0262Z00705

Distribution pattern

USA Nationwide Distribution