FDA Medical devices recall ·
Model Number SM-40HF-B-D-C recall
- Recall number
- Z-0274-2026
- Date
- (initiated June 10, 2025)
- Company / brand
- Sedecal Sa
Pelaya, 9 Pol., Algete, Spain - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 6 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Model Number SM-40HF-B-D-C; 40KW 80C, Mobile X-ray system
Why was it recalled?
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 should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI/DI 08436046001510, Serial Numbers: G39822, G62662, G62564, G61702, G60067, G38060.
Distribution
US: CA, IL, and NJ
States: California Illinois New Jersey
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0274-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.