Mobile X-ray System, Model: MUX-100, MUX-100H Product Usage: The device is a mobile X-ray sys...

FDA Device Recall #Z-1150-2014 — Class II — November 15, 2013

Recall Summary

Recall Number Z-1150-2014
Classification Class II — Moderate risk
Date Initiated November 15, 2013
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Shimadzu Medical Systems
Location Torrance, CA
Product Type Devices
Quantity 56 units

Product Description

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.

Distribution Pattern

USA Nationwide Distribution

Lot / 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

Other Recalls from Shimadzu Medical Systems

Recall # Classification Product Date
Z-0867-2022 Class II MODEL: X-RAY R/F SYSTEM FLUOROspeed X1 Jan 10, 2022
Z-0869-2022 Class II MODEL: X-RAY TV SYSSTEM SONIALVISION safire17 Jan 10, 2022
Z-0868-2022 Class II MODEL: X-RAY TV SYSTEM SONIALVISION G4 Jan 10, 2022
Z-0654-2022 Class II Digital Angiography System Bransist safire G... Dec 16, 2021
Z-0655-2022 Class II Digital Angiography System Shimadzu Trinias ... Dec 16, 2021

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.