Class 2 Device Recall MobileDaRt Evolution, Mobile XRay System

• Date Initiated by Firm: January 14, 2019
• Create Date: March 21, 2019
• Recall Status: Terminated on April 13, 2023
• Recall Number: Z-1039-2019
• Recall Event ID: 81940
• 510(K)Number: K080701
• Product Classification: System, x-ray, mobile - Product Code IZL
• Product: 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).
• 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
• Recalling Firm/ Manufacturer: Shimadzu Medical Systems Usa Com; 20101 S Vermont Ave; Torrance CA 90502-1328
• Manufacturer 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.
• FDA Determined Cause: Device Design
• Action: Shimadzu Medical Systems sent an Urgent Medical Device Correction Notice letter dated January 7, 2019 to customers. The letter identified the affected product, problem and actions to be taken. The corrective action for systems identified with this issue is replacement of the systems drive handle. Customers will be contacted by a Shimadzu or Fuji local Service Representative to determine whether your system requires the above correction action. For questions contact the Shimadzu National Service Support group at (844) 487-2767.
• Quantity in Commerce: 93 units
• Distribution: US Nationwide Distribution
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = IZL