SEDECAL SA: Model Number 40KWFXPLUS, Mobile X-ray system

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.

Details from the source

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. Distribution: US: CA, IL, and NJ Quantity: 268 units Lot/code info: UDI/DI 08436046002166, Serial Numbers: G75176, G75504, G76697, G78126, G78025, G78715, G78307, G79071, G79091, G79193, G80165, G79928, G76507, G79861, G80255, G80202, G82594, G79057, G73017, G80154, G73616, G73471, G76479, G79615, G80179, G79467, G79827, G79840, G79877, G79926, G78011, G78726, G82574, G82638, G73651, G75438, G77820, G78050, G79426, G79634, G82590, G72392, G73520, G73524, G73627, G73642, G73653, G76730, G76888, G78212, G78279, G78296, G78305, G78323, G82156, G83117, G83133, G73624, G82557, G84603, G84633, G84634, G84641, G84642, G84753, G84778, G84795, G84857, G84869, G84882, G84884, G84900, G84901, G84902, G84911, G84912, G85513, G85514, G85516, G85527, G85528, G79115, G79915, G72362, G75112, G75515, G79299, G79324, G73453, G79625, G77328, G75676, G75744, G75439, G78129, G78141, G76110, G76545, G78000, G80042, G73460, G75100, G75502, G84782, G79794, G83972, G84025, G79936, G84487, G75404, G73457, G75085, G79927, G75388, G73609, G76560, G78992, G82079, G82095, G84014, G75375, G75503, G75516, G73621, G73648, G72971, G77213, G79889, G77605, G79311, G75961, G77789, G84028, G73015, G73063, G78873, G79663, G79275, G73027, G76887, G79277, G79357, G76126, G75980, G76125, G76844, G77073, G77089, G77191, G77425, G73079, G75867, G83920, G84017, G77609, G77653, G84591, G75904, G75905, G73147, G73059, G77583, G77641, G77768, G77854, G77870, G77928, G84038, G72363, G73052, G75661, G75662, G75691, G84052, G72972, G73084, G73119, G76757, G76803, G84066, G77780, G73040, G7303

UPC codes

08436046002166

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.