SEDECAL SA 2025-10-29 Health serious FDA
Health · FDA · Recall #FDA-Z-0270-2026
Model Number SM-40HF-B-D-C; 40KW 55C/60C, Mobile X-ray system Recall
Issued October 29, 2025 · SEDECAL SA
In October 2025, SEDECAL SA recalled the Model Number SM-40HF-B-D-C; 40KW 55C/60C, Mobile X-ray system, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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.
What you should do
- 1 Stop using Model Number SM-40HF-B-D-C; 40KW 55C/60C, Mobile X-ray system right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact SEDECAL SA to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- SEDECAL SA
- Category
- Health
- Recall date
- October 29, 2025
- Units affected
- Not reported
- Sold at
- US: CA, IL, and NJ
- Recall number
- FDA-Z-0270-2026
- Made in
- Spain
- Issuing agency
- FDA
In context
- SEDECAL SA has 5 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 691st Health recall we've logged in 2025.