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
Check against the official notice below — it lists the full affected range.
Shimadzu Medical Systems USA is recalling 93 units of the MobileDaRt Evolution (MX8 Version) mobile x-ray system distributed nationwide. The recalled systems have a brake defect where the brakes fail to engage when the operator releases the drive handle, causing the device to continue moving and coasting uncontrollably even after the handle is released. This defect affects specific units manufactured during a designated period, identified by their serial numbers.
The recall notice does not specify what affected consumers should do regarding this product.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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: US Nationwide Distribution Quantity: 93 units Lot/code info: 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)045402170
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.