Recall Z-0248-2026 · IZL System, X-Ray, Mobile
SEDECAL SA
Model Number 40KWFXPLUS.004, Mobile X-ray system
| Date | Oct 23, 2025 (initiated Jun 10, 2025) |
| Status | Open, Classified |
| Reason | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning. |
| Root cause | Device Design |
| Action | Sedecal emailed their distributors on 06/10/2025 to remind them the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning. on 09/19/2025 the firm issued an Important Safety Notice to its direct consignees via email. This notice initiates Phase 2 of the recall strategy expanding the scope and providing information on stickers to cover gaps around the fine positioning control buttons and a DMC software update that stops unit movement if triggered by a short cicui |
| Quantity | 3 units |
| Distribution | US: CA, IL, and NJ |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K161345 | RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIR Sedecal., Sa., Jul 6, 2016 |