Recall Z-1084-2016 ยท IZL System, X-Ray, Mobile
Sedecal S.A.
Mobile wDR motorized portable diagnostic X-ray systems. Intended for use by a qualified/trained doctor or technologist on both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both adult and pediatric patients. Applications can be performed with patient sitting, standing or lying in the prone
| Date | Jan 18, 2016 |
| Status | Terminated |
| Reason | This is related to previous 806 Notifications about uncommanded movements of a motorized mobile x-ray system. Reason for Recall: Along with the previously noted encoder and gauges problems and corresponding fixes, we have observed that static electricity can also elicit the unwanted behavior. |
| Root cause | Device Design |
| Action | Philips Medical Systems sent an URGENT - Field Safety Notice letter dated August 6, 2014 was sent to all consignees of record informing them of a potential safety issue on the SEDECAL mobile units manufactured from May 2013 on. The firm requests the direct acounts with affected units should take the following steps: 1) The unit is equipped with a safety switch in the drive handle. If the drive handle is released the unit will stop; 2) Do not try to correct unintended movement using the controls on the drive handle; 3) Instead, stop the system immediately by releasing the drive handle entirel |
| Quantity | 349 systems |
| Distribution | Nationwide Distribution including AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NM, NY, OH, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K111725 | MOBILEDIAGNOST WDR Sedecal., Sa., Jul 19, 2011 |