CLASS II ONGOING Device recall · Reported 29 Oct 2025 · FDA Enforcement Report
Model Number SM-40HF-B-d-c; 40KW 55G/60G, Mobile X-ray system recalled
Sedecal is recalling Model Number SM-40HF-B-d-c; 40KW 55G/60G, Mobile X-ray system, distributed in California, Illinois, New Jersey. The recall was initiated on 10 Jun 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0268-2026
- FDA event ID
- 97075
- Recalling firm
- Sedecal, Algete
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 10 Jun 2025
- FDA classified
- 23 Oct 2025
- Reported
- 29 Oct 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Imaging Equipment
Timeline
| 10 Jun 2025 | Recall initiated by company | |
| 23 Oct 2025 | Classified by FDA | +135 days |
| 29 Oct 2025 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Product as listed by the FDA
Model Number SM-40HF-B-D-C; 40KW 55G/60G, Mobile X-ray system
Where it was distributed
US: CA, IL, and NJ
Questions about this recall
Is Model Number SM-40HF-B-d-c; 40KW 55G/60G, Mobile X-ray system recalled?
Yes. Sedecal recalled Model Number SM-40HF-B-d-c; 40KW 55G/60G, Mobile X-ray system on 10 Jun 2025. The recall is Class II and its status is Ongoing. Recall number Z-0268-2026.
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.
Which lots are affected?
UDI/DI 08436046001510, Serial Numbers: G35524, G33711.
Where was it sold?
US: CA, IL, and NJ
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Sedecal
All 57| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Model Number SM-40HF-B-d-c; 40KW Canon Ready, Mobile X-ray system recalled | Sedecal | Other | CA, IL, NJ |
| Device | CLASS II | Model SM-32HF-Batt; 32KW Analog, Mobile X-ray system recalled by Sedecal | Sedecal | Other | CA, IL, NJ |
| Device | CLASS II | Model Number SM-40HF-B-d-c; 40KW70CDEMO.005, Mobile X-ray system recalled | Sedecal | Other | CA, IL, NJ |
| Device | CLASS II | Model Number 40KWFX, Mobile X-ray system recalled by Sedecal | Sedecal | Other | CA, IL, NJ |
| Device | CLASS II | Model Number SM-40HF-B-d-c; 40KW 50G, Mobile X-ray system recalled | Sedecal | Other | CA, IL, NJ |
Other Imaging Equipment recalls
All 2,336| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep Clear recalled | Medline Industries | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Ultrasound Breast Pack recalled | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Alphenix Models Infx-8000C Infx-8000F Infx-8000V This device is recalled | Canon Medical System, USA | Other | Nationwide |
| Device | CLASS II | Merge PACS and Merge OrthoPACS recalled by Merge Healthcare | Merge Healthcare | Labeling Errors | Nationwide |
| Device | CLASS II | Philips Azurion recalled by Philips Medical Systems | Philips Medical Systems Nederland B.v | Lead & Heavy Metals |