United StatesSedecal Mobile Digital Diagnostic X‑Ray Systems (including SM‑40HF‑B‑D‑KM/AeroDR X30 and multiple MobileDiagnost and 40KWFX/40KWFXPLUS/SM series models) identified by the listed UDI/DI codes and serial numbers sold in CA, IL, and NJ are included in the recall. Sedecal advised the systems are not water‑resistant and reminded users to clean the equipment strictly according to the instructions in the manual.
What's being recalled
Sedecal Mobile Digital Diagnostic X-Ray Systems; SM-40HF-B-D-KM (AeroDR X30)
MobileDiagnost wDR 2.2; Model Number REF 9890-010-89522, Mobile X-ray system
Model Number 40KWFX, Mobile X-ray system
Model Number 40KW-FX.899, Mobile X-ray system
Model Number 40KWFXPLUS, Mobile X-ray system
Model Number 40KWFXPLUS.002, Mobile X-ray system
Model Number 40KWFXPLUS.004, Mobile X-ray system
Model Number 40KWFXPLUS.005, Mobile X-ray system
Model Number 40KWFXPLUS.889, Mobile X-ray system
Model Number 40KWFXPLUS-710CW, Mobile X-ray system
Model Number 40KWFXPLUS-710CW.007, Mobile X-ray system
Model Number 40KWMOBILE3.899, Mobile X-ray system
Model Number SM-20HF-Batt; 20KW ANALOG, Mobile X-ray system
Model Number SM-32HF-B-D-C; 32KW 50G, Mobile X-ray system
Model SM-32HF-Batt; 32KW ANALOG, Mobile X-ray system
And 27 more products.
Recalling firm: Sedecal Sa, Algete, Spain.
How to identify it
UDI/DI 08436046002593, Serial Numbers: G-81478, G81924, G84618, G87981, G88006, G88007, G87866, G84607, G86618, G88041, G87427, G80991, G-81936, G86688, G-82904, G86360, G84340, G86372, G81471, G86358, G86361, G87844, G87845, G85932, G86683, G84620, G84621, G85914, G87409, G87434, G84326, G84325, G-81925, G81923, G-81935, G84619, G-81934, G87426, G81002, G86686, G84339, G88042, G-82885, G-82887, G-82905, G84327, G85788, G85913, G85801, G86356, G87867, G88008, G87425, G86659, G88009, G87846. UDI/DI 08436046002357, Serial Numbers: SN11000007, SN13000099, SN13000100, SN13000101, 13000079, SN13000080, SN13000082, SN13000062, SN13000059, SN13000063, SN13000061, 13000067, 13000076, SN13000089, SN13000103, 13000085, SN13000146, 13000094, 13000092, 13000093, SN13000087, SN13000096, SN13000095, SN13000098, SN13000097, SN13000159, SN13000148, 13000145, 13000117, 14000051, SN13000149, 13000168, 14000015, 14000017, 14000014, 14000013, 14000019, 14000016, 13000167, 13000169, 14000011, 12000166, SN13000170, 13000200, 14000083, 14000008, 14000009, 13000201, SN13000179, SN13000181, 14000052, 14000026, 61918783, 14000049, 11000010, 13000068, 14000047, 14000041, 62072683, 62150154, 14000020, 62415613, SN14000097, SN14000096, 62587177, 14000116, 14000109, 14000119, 14000118, 14000126, 63604709, SN14000128, 64123668, 64216085, 14100105, 14100104, SN15100010, SN15100013, 15100104, 64904292, 15100100, 15100042, 15100040, 15100041, 15100226, 15100095, 65073897, 15100198, 15100116, 15100115, 15100127, 15100131, 15100135, 15100138, 15100144, 15100133, 14100034, SN14000127, 15100191, 66690596, 66936848, 15100274, 15100280, 15100276, SN16100008, 16100011, 67905914, 16100037, 16100038, 68025890, 68052381, 68054442, 68199970, 68233849, 68268597, 12000085, 68530038, 16200084, 16200028, 16200029, 16200049, 16200050, 16200051, 69022933, 16200064, 16200099, 70240554, 70378102, 70544668, 70545417, 70705340, 71001729, 72299716, 72555189, 21410094, 21410261, 21410347, 21410348, 22410146, 97579477…
The hazard
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 to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US: CA, IL, and NJ
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)