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).
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Shimadzu Medical Systems Usa Com
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full 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).
Product Codes/Lot Numbers:
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
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1039-2019
Related Recalls
Normal operation of the device is to power up the device in the morning, register the first patient, and then perform a fluoroscopy. If, however, the user powers up the device in the morning and makes an error by starting a fluoroscopy while the first patient is still being registered, the device application will abnormally terminate and require service intervention before it can be used again. This event will not occur after the first patient procedure.
TRINIAS for diagnostic imaging and interventional procedures in cardiac angiography, neurovascular angiography, abdominal angiography, peripheral angiography, rotational angiography, multi-purpose angiography and whole body radiographic/fluoroscopic procedures.
Shimadzu Medical Systems Usa Com
Two issues: Event 1: Normal operation of the device is to power up the device in the morning, register the first patient, and then perform a fluoroscopy. If, however, the user powers up the device in the morning and makes an error by starting a fluoroscopy while the first patient is still being registered, the device application will abnormally terminate and require service intervention before it can be used again. This event will not occur after the first patient procedure. Event 2: In rare cases a synchronization error may occur in the data transmission circuit in the device due to external noise. The visibility of the displayed image may be corrupted (images become bit-shifted abnormal images). If this event occurs, it may become difficult to see the object, which may hinder the examination and treatment.
TRINIAS Digital Angiographic System intended to be used for cardiac angiography, neurovascular angiography, abdominal angiography, peripheral angiography, rotational angiography, multi-purpose angiography and whole body radiographic/fluoroscopic procedures.
Shimadzu Medical Systems Usa Com
Due to a software issue the C-arm may unexpectedly moved when being moved to the park position and during specific operations. There is a possibility the C-arm will come into contact with a patient or healthcare personnel.