SHIMADZU MobileDaRt Evolution (MX8 Version), Mobile X-Ray System Product Usage: This device i...
FDA Device Recall #Z-1039-2019 — Class II — January 14, 2019
Recall Summary
| Recall Number | Z-1039-2019 |
| Classification | Class II — Moderate risk |
| Date Initiated | January 14, 2019 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Shimadzu Medical Systems Usa Com |
| Location | Torrance, CA |
| Product Type | Devices |
| Quantity | 93 units |
Product Description
SHIMADZU MobileDaRt Evolution (MX8 Version), Mobile X-Ray System Product Usage: This device is intended to be used to take a film, CR or general radiography of patients in the hospital who cannot move and/or of outpatients in emergency. Exposure can be captured on film, CR or Digital Radiography (DR).
Reason for Recall
In these units, the brake is usually released by gripping the drive handle and applied by letting go of the handle. However, for systems within a specified manufacture period, we have identified that even when letting go of the handle, the systems brakes are not applied. In this event, if the Operator releases the handle when the device is moving, the unit will continue to coast.
Distribution Pattern
US Nationwide Distribution
Lot / Code Information
Serial Numbers: S/N UDI 41F41DD7C001 (01)04540217059621(11)171214(21)41F41DD7C001 41F41DD7C002 (01)04540217059621(11)171214(21)41F41DD7C002 41F41DD7C003 (01)04540217059621(11)171214(21)41F41DD7C003 41F41DD7C004 (01)04540217059621(11)171215(21)41F41DD7C004 41F41DD7C005 (01)04540217059621(11)171215(21)41F41DD7C005 41F41DD7C006 (01)04540217059621(11)171215(21)41F41DD7C006 41F41DD7C007 (01)04540217059621(11)171215(21)41F41DD7C007 41F41DD7C008 (01)04540217059621(11)171215(21)41F41DD7C008 41F41DD7C009 (01)04540217059621(11)171225(21)41F41DD7C009 41F41DD7C010 (01)04540217059621(11)171225(21)41F41DD7C010 41F41DD81001 (01)04540217059621(11)180115(21)41F41DD81001 41F41DD81002 (01)04540217059621(11)180115(21)41F41DD81002 41F41DD81003 (01)04540217059621(11)180116(21)41F41DD81003 41F41DD81004 (01)04540217059621(11)180116(21)41F41DD81004 41F41DD81005 (01)04540217059621(11)180117(21)41F41DD81005 41F41DD81006 (01)04540217059621(11)180118(21)41F41DD81006 41F41DD81007 (01)04540217059621(11)180118(21)41F41DD81007 41F41DD81008 (01)04540217059621(11)180119(21)41F41DD81008 41F41DD81009 (01)04540217059621(11)180119(21)41F41DD81009 41F41DD81010 (01)04540217059621(11)180119(21)41F41DD81010 41F41DD81011 (01)04540217059621(11)180122(21)41F41DD81011 41F41DD81012 (01)04540217059621(11)180122(21)41F41DD81012 41F41DD81013 (01)04540217059621(11)180123(21)41F41DD81013 41F41DD81014 (01)04540217059621(11)180123(21)41F41DD81014 41F41DD81015 (01)04540217059621(11)180123(21)41F41DD81015 41F41DD82001 (01)04540217059621(11)180207(21)41F41DD82001 41F41DD82002 (01)04540217059621(11)180213(21)41F41DD82002 41F41DD82003 (01)04540217059621(11)180213(21)41F41DD82003 41F41DD82004 (01)04540217059621(11)180213(21)41F41DD82004 41F41DD82005 (01)04540217059621(11)180213(21)41F41DD82005 41F41DD82006 (01)04540217059621(11)180213(21)41F41DD82006 41F41DD82007 (01)04540217059621(11)180213(21)41F41DD82007 41F41DD82008 (01)04540217059621(11)180213(21)41F41DD82008 41F41DD82009 (01)04540217059621(11)180213(21)41F41DD82009 41F41DD82010 (01)04540217059621(11)180214(21)41F41DD82010 41F41DD82011 (01)04540217059621(11)180214(21)41F41DD82011 41F41DD82012 (01)04540217059621(11)180214(21)41F41DD82012 41F41DD82013 (01)04540217059621(11)180214(21)41F41DD82013 41F41DD82014 (01)04540217059621(11)180215(21)41F41DD82014 41F41DD82015 (01)04540217059621(11)180220(21)41F41DD82015 41F41DD82017 (01)04540217059621(11)180223(21)41F41DD82017 41F41DD82018 (01)04540217059621(11)180223(21)41F41DD82018 41F41DD83001 (01)04540217059621(11)180306(21)41F41DD83001 41F41DD83002 (01)04540217059621(11)180306(21)41F41DD83002 41F41DD83003 (01)04540217059621(11)180307(21)41F41DD83003 41F41DD83004 (01)04540217059621(11)180307(21)41F41DD83004 41F41DD83005 (01)04540217059621(11)180307(21)41F41DD83005 41F41DD83006 (01)04540217059621(11)180307(21)41F41DD83006 41F41DD83007 (01)04540217059621(11)180308(21)41F41DD83007 41F41DD83008 (01)04540217059621(11)180308(21)41F41DD83008 41F41DD83009 (01)04540217059621(11)180308(21)41F41DD83009 41F41DD83010 (01)04540217059621(11)180308(21)41F41DD83010 41F41DD83011 (01)04540217059621(11)180309(21)41F41DD83011 41F41DD83012 (01)04540217059621(11)180309(21)41F41DD83012 41F41DD83013 (01)04540217059621(11)180312(21)41F41DD83013 41F41DD83014 (01)04540217059621(11)180312(21)41F41DD83014 41F41DD83015 (01)04540217059621(11)180313(21)41F41DD83015 41F41DD83016 (01)04540217059621(11)180315(21)41F41DD83016 41F41DD83017 (01)04540217059621(11)180319(21)41F41DD83017 41F41DD83018 (01)04540217059621(11)180319(21)41F41DD83018 41F41DD83019 (01)04540217059621(11)180320(21)41F41DD83019 41F41DD83020 (01)04540217059621(11)180321(21)41F41DD83020 41F41DD83021 (01)04540217059621(11)180321(21)41F41DD83021 41F41DD83022 (01)04540217059621(11)180322(21)41F41DD83022 41F41DD83023 (01)04540217059621(11)180326(21)41F41DD83023 41F41DD83024 (01)04540217059621(11)180326(21)41F41DD83024 41F41DD83025 (01)04540217059621(11)180326(21)41F41DD83025 41F41DD83026 (01)04540217059621(11)180327(21)41F41DD83026 41F41DD83027 (01)04540217059621(11)180327(21)41F41DD83027 41F41DD83028 (01)04540217059621(11)180327(21)41F41DD83028 41F41DD84001 (01)04540217059621(11)180403(21)41F41DD84001 41F41DD84002 (01)04540217059621(11)180411(21)41F41DD84002 41F41DD84003 (01)04540217059621(11)180411(21)41F41DD84003 41F41DD84004 (01)04540217059621(11)180411(21)41F41DD84004 41F41DD84005 (01)04540217059621(11)180412(21)41F41DD84005 41F41DD84006 (01)04540217059621(11)180412(21)41F41DD84006 41F41DD84007 (01)04540217059621(11)180413(21)41F41DD84007 41F41DD84008 (01)04540217059621(11)180413(21)41F41DD84008 41F41DD84009 (01)04540217059621(11)180413(21)41F41DD84009 41F41DD84010 (01)04540217059621(11)180416(21)41F41DD84010 41F41DD84011 (01)04540217059621(11)180416(21)41F41DD84011 41F41DD84012 (01)04540217059621(11)180417(21)41F41DD84012 41F41DD84013 (01)04540217059621(11)180419(21)41F41DD84013 41F41DD84014 (01)04540217059621(11)180420(21)41F41DD84014 41F41DD84015 (01)04540217059621(11)180423(21)41F41DD84015 41F41DD84016 (01)04540217059621(11)180425(21)41F41DD84016 41F41DD84017 (01)04540217059621(11)180425(21)41F41DD84017 41F41DD84018 (01)04540217059621(11)180425(21)41F41DD84018 41F41DD84019 (01)04540217059621(11)180426(21)41F41DD84019 41F41DD85001 (01)04540217059621(11)180502(21)41F41DD85001 41F41DD85002 (01)04540217059621(11)180502(21)41F41DD85002 41F41DD85003 (01)04540217059621(11)180507(21)41F41DD85003 41F41DD85004 (01)04540217059621(11)180507(21)41F41DD85004
Other Recalls from Shimadzu Medical Systems Usa Com
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0959-2019 | Class II | BRANSIST safire Product Usage: DIGITAL ANGI... | Jan 14, 2019 |
| Z-0864-2019 | Class II | TRINIAS for diagnostic imaging and intervention... | Jan 14, 2019 |
| Z-0197-2019 | Class II | TRINIAS Digital Angiographic System intended to... | Jun 15, 2018 |
| Z-2654-2017 | Class II | SHIMADZU RADspeed Pro Catalog Number: RADspeed ... | May 23, 2017 |
| Z-2655-2017 | Class II | SHIMADZU FDR Visionary Catalog Number: FDR Vi... | May 23, 2017 |
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.