FDA (Devices) recall action 97075
The FDA (Devices) publishes a recall like this one as 46 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 46 pages.
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.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Sedecal is recalling two SM-40HF-B-D-C 40KW 55G/60G mobile X-ray systems after emailing consignees to remind users that the equipment is not water-resistant.
Sedecal is recalling four SM-40HF-B-D-C 40KW 50C mobile X-ray systems after emailing consignees to remind users that the equipment is not water-resistant.
Sedecal is recalling 27 SM-40HF-B-D-C 40KW 50G mobile X-ray systems after emailing consignees to remind users that the equipment is not water-resistant.
Sedecal is recalling 22 SM-32HF-Batt 32KW analog mobile X-ray systems after emailing consignees to remind users that the equipment is not water-resistant.
Sedecal is recalling 24 RadPro Mobile X-ray systems after emailing consignees to remind users that the equipment is not water-resistant.
Sedecal is recalling four SM-40HF-B-D-C 40KW 55C/60C mobile X-ray systems after emailing consignees to remind users that the equipment is not water-resistant.
Sedecal is recalling eight SM-32HF-B-D-C 32KW 50G mobile X-ray systems after emailing consignees to remind users that the equipment is not water-resistant.
Sedecal is recalling 55 model 40KWFX mobile X-ray systems after emailing consignees to remind users that the equipment is not water-resistant.
Sedecal is recalling 12 model 40KWFXPLUS.005 mobile X-ray systems after emailing consignees to remind users that the equipment is not water-resistant.
Sedecal is recalling five SM-40HF-B-D-C 40KW 55G mobile X-ray systems after emailing consignees to remind users that the equipment is not water-resistant.
Sedecal is recalling seven model 40KWFXPLUS-710CW.007 mobile X-ray systems after emailing consignees to remind users that the equipment is not water-resistant.
Sedecal is recalling three SM_40HF_B_D_VIR3.004 mobile X-ray systems after emailing consignees to remind users that the equipment is not water-resistant.
Sedecal is recalling 181 SM-40HF-B-D-C 40KW 70C mobile X-ray systems after emailing consignees to remind users that the equipment is not water-resistant.
Sedecal is recalling one SM-40HF-B-D-C 40KW 70C EN mobile X-ray system after emailing consignees to remind users that the equipment is not water-resistant.
Sedecal is recalling 39 SM-40HF-B-D-C 40KW 50G mobile X-ray systems after emailing consignees to remind users that the equipment is not water-resistant.
Sedecal is recalling 14 SM-40HF-B-D-C 40KW 70C mobile X-ray systems after emailing consignees to remind users that the equipment is not water-resistant.
Sedecal is recalling six SM-40HF-B-D-C 40KW Canon Ready mobile X-ray systems after emailing consignees to remind users that the equipment is not water-resistant.
Sedecal is recalling eight Easy Moving Plus SM-50HF-B-D-C 50KW 50G mobile X-ray systems after emailing consignees to remind users that the equipment is not water-resistant.
Sedecal is recalling six SM-40HF-B-D-C 40KW.005 mobile X-ray systems after emailing consignees to remind users that the equipment is not water-resistant.
Sedecal is recalling 142 SM-40HF-B-D-C 40KW mobile X-ray systems after emailing consignees to remind users that the equipment is not water-resistant.
Sedecal is recalling 10 mobile X-ray systems after emailing consignees to remind users that the equipment is not water-resistant and must be cleaned strictly per the manual.