0.7/1.2JG326D-265 Product Usage: The device is a mobile X-ray system in order to take gene...

FDA Device Recall #Z-0264-2013 - Class II, October 28, 2011

Recall Summary

Recall Number Z-0264-2013
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 5 units

Product Description

0.7/1.2JG326D-265 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

MobileArt Evolution (12.5 kW) S/N of X-ray tube: 2XY0090049 2XY0090052 2XY0090062 2XY0090388 2XY0092824 2XY0092822 2XY0094944 2XY0094940 2XY0095628 2XY0095975 2XY0095996 2XY0097550 2XY0097539 2XY0000035 2XY0090058 MobileArt Evolution (32 kW) S/N of X-ray tube: 2XY0092847 2XY0092851 2XY0092850 2XY0093893 2XY0093890 2XY0093561 2XY0096822 2XY0096828 2XY0097579 2XY0000834 2XY0001079 2XY0001215 2XY0001200 2XY0001311 2XY0001216 2XY0001312 2XY0001214 2XY0001377 2XY0001374 2XY0001383 2XY0001488 2XY0001653 2XY0001478 2XY0001657 2XY0001658 2XY0001674 2XY0001672 2XY0001644 2XY0002081 2XY0002281 2XY0002088 2XY0002083 2XY0002289 2XY0001827 CM74B3012026 2XY0003774 2XY0004043

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.