Recall Z-0182-2023 ยท IZL System, X-Ray, Mobile
SEDECAL SA
Sedecal Soltus Battery Mobile X-Ray System REF Soltus 450 Battery Mobile X-Ray System REF Soltus 500
| Date | Nov 4, 2022 (initiated Aug 12, 2022) |
| Status | Open, Classified |
| Reason | Due to un-commanded movement of mobile x-ray unit. |
| Root cause | Software design |
| Action | Sedecal SA provided Canon Medical Systems USA (CMSU) the sole distributor of the Soltus system in the U.S. an "URGENT: ADVISORY NOTICE" to communicated to CMSU's customers. On 07/28/2022, CMSU sent the "URGENT: ADVISORY NOTICE" Letter via USPS Certified to inform customer of an issue with erratic movements related with Soltus 500 Mobile X-Ray units. According to reports, the users were trying to turn the systems to the left or to the right when it suddenly started moving backwards at a high speed. Customer are instructed to: 1. Do not continue using the unit when in error condition (magenta |
| Quantity | 155 systems |
| Distribution | U.S.: KY, WI, FL, DE, WV, CA, MO, NY, NC, AL, AR, MS, GA, IL, IA, TN, KS, KY, IN, HI, OH, WY, PA, NV, RI, UT, AZ, OK, MN, ME, MT, WA, VA, SD, MI, LA, and TX O.U.S.: N/A |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K192936 | Soltus 500 Sedecal., Sa., Nov 15, 2019 |