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0.7U163CS-36 In combination with below systems MUX-100H, MUX-100D, MobileArt Evolution Bra...

FDA Device Recall #Z-0262-2013 — Class II — October 28, 2011

Recall Summary

Recall Number Z-0262-2013
Classification Class II — Moderate risk
Date Initiated October 28, 2011
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Shimadzu Medical Systems
Location Torrance, CA
Product Type Devices
Quantity 288 units

Product Description

0.7U163CS-36 In combination with below systems MUX-100H, MUX-100D, MobileArt Evolution Brand Name: MUX-100H. Classification Name: Mobile x-ray system. Device Model#MUX-100H. Product Usage: The device is a mobile X-ray system in order to take general radiography of patients in the hospital who cannot move and/or of outpatients in emergency.

Reason for Recall

Shimadzu is recalling Diagnostic X-ray Beam-Limiting Device, Mobile x-ray system and Diagnostic x-ray tube assembly because they do not comply with the Product Performance Standards, 21CFR 1020.30 (m) Beam quality --(1) Half-value layer (HVL), which was revised in 2006. Certain devices might not comply with the requirements for them in some x-ray generating condition after the revision in 2006.

Distribution Pattern

US Nationwide Distribution

Lot / Code Information

S/N of X-ray tube: 63049 63048 63074 63081 63082 63077 63350 63349 63629 63647 63909 62729 64214 66033 66032 70070 70065 70364 66327 66331 70058 66325 70955 71241 70920 71848 72472 72462 73056 73058 73341 73675 74577 74563 74565 74557 74558 74846 74845 75455 75452 75457 75728 75737 75736 76059 76057 76060 76054 76062 76360 76366 76612 76636 76336 76916 76655 76647 76938 76940 2XY080646 2XY0081249 2XY0081245 2XY0081543 2XY0081858 2XY0081849 2XY0081855 2XY0081856 2XY0081865 2XY0081862 2XY0082746 2XY0082764 2XY0083055 2XY0083052 2XY0083064 2XY0083051 2XY0083053 2XY0083038 2XY0083063 2XY0083063 2XY0083065 2XY0083343 2XY0083340 2XY0083349 2XY0083354 2XY0083360 2XY0083355 2XY0083646 2XY0083359 2XY0083652 2XY0083670 2XY0083674 2XY0083655 2XY0083673 2XY0083675 2XY0083665 2XY0083645 2XY0083643 2XY0083629 2XY0074577 2XY0083638 2XY0083943 2XY0083671 2XY0083933 2XY0083930 2XY0083925 2XY0084532 2XY0084558 2XY0084546 2XY0084553 2XY0084538 2XY0084846 2XY0084565 2XY0084845 2XY0085124 2XY0085137 2XY0085127 2XY0084578 2XY0085140 2XY0085143 2XY0085141 2XY0086351 2XY0084860 2XY0084856 2XY0084851 2XY0084859 2XY0086344 2XY0084852 2XY0086365 2XY0086364 2XY0086373 2XY0086368 2XY0086665 2XY0086674 2XY0087077 2XY0087371 2XY0087044 2XY0087036 2XY0087041

Other Recalls from Shimadzu Medical Systems

Recall # Classification Product Date
Z-2294-2026 Class II Digital Angiography System Trinias:UD150G-40 / ... Apr 20, 2026
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

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.

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