Recall Z-2390-2015 ยท IZL System, X-Ray, Mobile
Sedecal S.A.
RadPro 40kW Digital X-Ray Panel and Mobile/Portable Diagnostic X-Ray. Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts.
| Date | Aug 14, 2015 (initiated Jul 13, 2015) |
| Status | Terminated |
| Reason | Electrostatic energy may be stored in Systems that can cause a short-cicuit which, in turn, can generate an Electomagnetic Pulse which might disturb the electronics of the Digital Motion Control Board producing uncontrolled movements and such uncontrolled movements could cause the system to bump into the user or ppatient. |
| Root cause | Device Design |
| Action | FIELD CORRECTION NOTIFICATION letters dated July 13, 2015 were sent to all dealers. The letters instructed the dealers: to schedule the replacement of the current arrestor by a new design of resistive arrestor with a resistance of 1 M ohm between frame and floor (ground). Although the metallic arrestor is only implemented in the equipments manufactured from April 2013 till March 2015, the upgrade kit has to be implemented in all the installed base of Mobiles with the same configuration in order to ensure that even the arrestors installed as spare part are replaced. Sedecal will provide t |
| Quantity | 361 systems (U.S.); 5 systems (Foreign) |
| Distribution | Distributed US (nationwide) and in Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K101517 | SEDECAL MOBILE DIGITAL DIAGNOSTIC X-RAY Sedecal., Sa., Aug 5, 2011 |