SEDECAL SA: MobileDiagnost wDR 2.2; Model Number REF 9890-010-89522, 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: 1198 units Lot/code info: 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,

UPC codes

08436046002357

Source

Official record: FDA (Device enforcement) ↗

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