CLASS II ONGOING Device recall · Reported 29 Oct 2025 · FDA Enforcement Report
Model Number 40KWMOBILE3.899, Mobile X-ray system recalled by Sedecal
Sedecal is recalling Model Number 40KWMOBILE3.899, 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
Lot, batch or date codes UDI/DI unknown, Serial Numbers: G64852
Quantity recalled 1 unit
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-0253-2026
FDA event ID 97075
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 E-Mail
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 40KWMOBILE3.899, Mobile X-ray system
Questions about this recall
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 unknown, Serial Numbers: G64852
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event 45 other products · FDA event 97075 This product is part of a recall event; the main page for the event is MobileDiagnost wDR recalled by Sedecal .
Reported Class Recall Company Reason Where 29 Oct 2025 CLASS II MobileDiagnost wDR recalled by Sedecal Sedecal Other CA, IL, NJ 29 Oct 2025 CLASS II Model Number SM-32HF-B-d-c; 32KW 50G, Mobile X-ray system recalled Sedecal Other CA, IL, NJ 29 Oct 2025 CLASS II Model Number 40KWFXPLUS.004, Mobile X-ray system recalled by Sedecal Sedecal Other CA, IL, NJ 29 Oct 2025 CLASS II Model Number SM-40HF-B-d-c; 40KW 55C/60C, Mobile X-ray system recalled Sedecal Other CA, IL, NJ 29 Oct 2025 CLASS II Model Number SM-40HF-B-d-c; 40KW, Mobile X-ray system recalled Sedecal Other CA, IL, NJ 29 Oct 2025 CLASS II Model Number SM-40HF-B-d-c; 40KW 70C, Mobile X-ray system recalled Sedecal Other CA, IL, NJ 29 Oct 2025 CLASS II SM_40HF_B_D_VIR3, Mobile X-ray system recalled by Sedecal Sedecal Other CA, IL, NJ 29 Oct 2025 CLASS II SM_40HF_BDC3, Mobile X-ray system recalled by Sedecal Sedecal Other CA, IL, NJ 29 Oct 2025 CLASS II Model Number SM-20HF-Batt; 20KW Analog, Mobile X-ray system recalled Sedecal Other CA, IL, NJ 29 Oct 2025 CLASS II Shimadzu RF.004, Mobile X-ray system recalled by Sedecal Sedecal Other CA, IL, NJ 29 Oct 2025 CLASS II Model Number SM-40HF-B-d-c; 40KW.002, Mobile X-ray system recalled Sedecal Other CA, IL, NJ 29 Oct 2025 CLASS II Model Number 40KW-FX.899, Mobile X-ray system recalled by Sedecal Sedecal Other CA, IL, NJ 29 Oct 2025 CLASS II Model Number 40KWFXPLUS-710CW.007, Mobile X-ray system recalled Sedecal Other CA, IL, NJ 29 Oct 2025 CLASS II Model SM-40HF-B-d-c; 40KW - Canon Ready, Mobile X-ray system recalled Sedecal Other CA, IL, NJ 29 Oct 2025 CLASS II Model Number SM-40HF-B-d-c; 40KW.005, Mobile X-ray system recalled Sedecal Other CA, IL, NJ 29 Oct 2025 CLASS II SM_40HF_B_D_VIR3.004, Mobile X-ray system recalled by Sedecal Sedecal Other CA, IL, NJ 29 Oct 2025 CLASS II Model Number 40KWFXPLUS.889, Mobile X-ray system recalled by Sedecal Sedecal Other CA, IL, NJ 29 Oct 2025 CLASS II Model Number SM-40HF-B-d-c; 40KW 55C, Mobile X-ray system recalled Sedecal Other CA, IL, NJ 29 Oct 2025 CLASS II Model Number SM-40HF-B-d-c; 40KW 55G/60G, Mobile X-ray system recalled Sedecal Other CA, IL, NJ 29 Oct 2025 CLASS II SM_40HF_BDC, Mobile X-ray system recalled by Sedecal Sedecal Other CA, IL, NJ 29 Oct 2025 CLASS II Radpro Mobile, Mobile X-ray system recalled by Sedecal Sedecal Other CA, IL, NJ 29 Oct 2025 CLASS II Mobile Digital Diagnostic X-Ray Systems recalled by Sedecal Sedecal Other CA, IL, NJ 29 Oct 2025 CLASS II Model Number 40KWFXPLUS.005, Mobile X-ray system recalled by Sedecal Sedecal Other CA, IL, NJ 29 Oct 2025 CLASS II Model Number SM-40HF-B-d-c; 40KW 80C, Mobile X-ray system recalled Sedecal Other CA, IL, NJ 29 Oct 2025 CLASS II Model Number 40KWFXPLUS.002, Mobile X-ray system recalled by Sedecal Sedecal Other CA, IL, NJ 29 Oct 2025 CLASS II Model Number SM-40HF-B-d-c; 40KW 55G, Mobile X-ray system recalled Sedecal Other CA, IL, NJ 29 Oct 2025 CLASS II Easy Moving Plus recalled by Sedecal Sedecal Other CA, IL, NJ 29 Oct 2025 CLASS II Model Number SM-40HF-B-d-c; 40KW 55C, Mobile X-ray system recalled Sedecal Other CA, IL, NJ 29 Oct 2025 CLASS II Model SM-40HF-B-d-c; 40KW 70C, Mobile X-ray system recalled by Sedecal Sedecal Other CA, IL, NJ 29 Oct 2025 CLASS II Model Number SM-40HF-B-d-c; 40KW 55C, Mobile X-ray system recalled Sedecal Other CA, IL, NJ 29 Oct 2025 CLASS II Model Number 40KWFXPLUS-710CW, Mobile X-ray system recalled by Sedecal Sedecal Other CA, IL, NJ 29 Oct 2025 CLASS II Model Number SM-40HF-B-d-c; 40KW 70C Ready, Mobile X-ray system recalled Sedecal Other CA, IL, NJ 29 Oct 2025 CLASS II Model Number SM-40HF-B-d-c; 40KW 50G, Mobile X-ray system recalled Sedecal Other CA, IL, NJ 29 Oct 2025 CLASS II SED URS LP, Mobile X-ray system recalled by Sedecal Sedecal Other CA, IL, NJ 29 Oct 2025 CLASS II Model Number SM-40HF-B-d-c; 40KW 50C, Mobile X-ray system recalled Sedecal Other CA, IL, NJ 29 Oct 2025 CLASS II Model Number SM-40HF-B-d-c; 40KW 70C EN, Mobile X-ray system recalled Sedecal Other CA, IL, NJ 29 Oct 2025 CLASS II Model Number SM-40HF-B-d-c; 40KW Canon Ready.005 recalled by Sedecal Sedecal Other CA, IL, NJ 29 Oct 2025 CLASS II Model Number 40KWFXPLUS, Mobile X-ray system recalled by Sedecal Sedecal Other CA, IL, NJ 29 Oct 2025 CLASS II Model Number SM-40HF-Batt; 40KW Analog, Mobile X-ray system recalled Sedecal Other CA, IL, NJ 29 Oct 2025 CLASS II Model Number SM-40HF-B-d-c; 40KW 55C/60C, Mobile X-ray system recalled Sedecal Other CA, IL, NJ 29 Oct 2025 CLASS II Model Number SM-40HF-B-d-c; 40KW 50G, Mobile X-ray system recalled Sedecal Other CA, IL, NJ 29 Oct 2025 CLASS II Model Number 40KWFX, Mobile X-ray system recalled by Sedecal Sedecal Other CA, IL, NJ 29 Oct 2025 CLASS II Model Number SM-40HF-B-d-c; 40KW70CDEMO.005, Mobile X-ray system recalled Sedecal Other CA, IL, NJ 29 Oct 2025 CLASS II Model SM-32HF-Batt; 32KW Analog, Mobile X-ray system recalled by Sedecal Sedecal Other CA, IL, NJ 29 Oct 2025 CLASS II Model Number SM-40HF-B-d-c; 40KW Canon Ready, Mobile X-ray system recalled Sedecal Other CA, IL, NJ
More recalls from Sedecal All 57 Reported Class Recall Company Reason Where 29 Oct 2025 Device CLASS II Model Number SM-40HF-B-d-c; 40KW Canon Ready, Mobile X-ray system recalled Sedecal Other CA, IL, NJ 29 Oct 2025 Device CLASS II Model SM-32HF-Batt; 32KW Analog, Mobile X-ray system recalled by Sedecal Sedecal Other CA, IL, NJ 29 Oct 2025 Device CLASS II Model Number SM-40HF-B-d-c; 40KW70CDEMO.005, Mobile X-ray system recalled Sedecal Other CA, IL, NJ 29 Oct 2025 Device CLASS II Model Number 40KWFX, Mobile X-ray system recalled by Sedecal Sedecal Other CA, IL, NJ 29 Oct 2025 Device CLASS II Model Number SM-40HF-B-d-c; 40KW 50G, Mobile X-ray system recalled Sedecal Other CA, IL, NJ