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 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 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 one SM_40HF_BDC mobile X-ray system after emailing consignees to remind users that the equipment is not water-resistant.
Sedecal is recalling 56 SM-40HF-B-D-KM (AeroDR X30) mobile digital diagnostic X-ray systems after emailing consignees to remind users that the equipment is not water-resistant.
Sedecal is recalling one SM-20HF-Batt 20KW analog mobile X-ray system 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 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 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 1,198 MobileDiagnost wDR 2.2 mobile X-ray systems after emailing consignees to remind users that the equipment is not water-resistant.
Sedecal is recalling eight model 40KWFXPLUS.002 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 80C 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 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 three model 40KWFXPLUS.004 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 one SM_40HF_BDC3 mobile X-ray system after emailing consignees to remind users that the equipment is not water-resistant.
Sedecal is recalling one SM-40HF-B-D-C 40KW Canon Ready mobile X-ray system after emailing consignees to remind users that the equipment is not water-resistant.
Sedecal is recalling the SHIMADZU RF.004 mobile X-ray system, serial 75723, 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 six SM-40HF-B-D-C 40KW.002 mobile X-ray systems after emailing consignees to remind users that the equipment is not water-resistant.
Sedecal is recalling one 40KW-FX.899 mobile X-ray system after emailing consignees to remind users that the equipment is not water-resistant.