Mobile X-ray System — Class II medical device recall Z-1150-2014
Terminated recall by Shimadzu Medical Systems, reported 2014-03-12, distributed nationwide. Shimadzu Corporation is recalling the Shimadzu Mobile X-ray Sytems (MUX-100 and MUX-100H) because the connecti
| Recall number | Z-1150-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Shimadzu Medical Systems, Torrance, CA, United States |
| Recall initiated | 2013-11-15 |
| Classified | 2014-03-06 |
| Reported by FDA | 2014-03-12 |
| Terminated | 2015-06-25 |
| Distributed | Nationwide (US) |
| Quantity | 56 units |
| Reason classes | packaging |
| Serial numbers | 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 and 31 more |
| Model numbers | MUX-100, MUX-100H |
Product
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
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.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.