Recall Z-1203-2023 ยท IZL System, X-Ray, Mobile
SEDECAL SA
Phoenix mKDR Xpress, digital mobile diagnostic x-ray system
| Date | Mar 2, 2023 (initiated Feb 6, 2023) |
| Status | Open, Classified |
| Reason | Sedecal was informed of 3 incidents of erratic movements related to X-ray mobile systems. |
| Root cause | Device Design |
| Action | Sedecal issued an URGENT MEDICAL DEVICE RECALL notice to its US distributor on 02/06/2023 by email. The notice explained the issue and requested that distributor to warn its customers about the risk of potential erratic movement and provided a list of precautions until the software is installed. Questions may be directed to calidad-clientes@sedecal.com. |
| Quantity | 7 units |
| Distribution | US, Argentina, Panama |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K221803 | PHOENIX/AeroDR TX m01 and PHOENIX/mKDR Xpress. Sedecal., Sa., Jul 18, 2022 |