Recall Z-1039-2019 ยท IZL System, X-Ray, Mobile
Shimadzu Medical Systems Usa Com
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).
| Date | Jan 14, 2019 |
| Status | Terminated |
| Reason | 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. |
| Root 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 | 93 units |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K080701 | SHIMADZU MOBILE X-RAY SYSTEM MOBILEDART EVOLUTION Shimadzu Corp., May 14, 2008 |