Hologic, Inc.: Hologic 3Dimensions/Selenia Dimensions Models: RM-SDM-00001-3D SDM-00001-2D SDM-00001-3D SDM-05000-3D3 SDM-05000-2DC SDM-00001-M3D SDM-05000-3DC SDM-SYS-6000-3D SDM-05000-2D3 SDA-SYS-30

Hazard

C-Arm unexpected movement may cause blunt trauma should the tube arm impinge upon an individual

Details from the source

Reason for recall: C-Arm unexpected movement may cause blunt trauma should the tube arm impinge upon an individual Distribution: US Nationwide distribution. Quantity: 797 units Lot/code info: UDI: 15420045508019; 15420045505636 Serial Numbers; 81001090068 81001100177 81001110594 81001110612 81001110627 81001121279 81001132051 81001132057 81001132096 81001142983 81001142990 81001142995 81001143035 81001143051 81001143060 81001143068 81001143071 81001154286 81001154309 81001154310 81001154320 81001154322 81001154340 81001165989 81001165997 81001165999 81001166000 81001166015 81001166073 81001166090 81001166094 81001166098 81001166109 81001166119 81001166124 81001177755 81001177759 81001177764 81001177803 81001177809 81001177819 81001177820 81001177822 81001177826 81001177829 81001177832 81001177844 81001177851 81001177853 81002100189 81002100197 81002110651 81002110662 81002110663 81002110664 81002121291 81002121328 81002132113 81002143090 81002143092 81002143112 81002143142 81002143144 81002143146 81002143151 81002154368 81002154378 81002154384 81002154388 81002154403 81002154405 81002154434 81002154449 81002154452 81002154459 81002154466 81002154467 81002154475 81002154479 81002154480 81002154484 81002166176 81002166178 81002166212 81002166220 81002166252 81002166256 81002166308 81002177848 81002177861 81002177882 81002177883 81002177897 81002177898 81002177899 81002177923 81002177941 81003090087 81003090092 81003110694 81003110696 81003110709 81003110728 81003110747 81003121404 81003132209 81003132220 81003154491 81003154508 81003154513 81003154514 81003154566 81003154567 81003154578 81003154579 81003154588 81003154595 81003154596 81003154598 81003154621 81003154

UPC codes

15420045508019, 15420045505636, 81001090068, 81001100177, 81001110594, 81001110612, 81001110627, 81001121279, 81001132051, 81001132057, 81001132096, 81001142983, 81001142990, 81001142995, 81001143035, 81001143051, 81001143060, 81001143068, 81001143071, 81001154286, 81001154309, 81001154310, 81001154320, 81001154322, 81001154340, 81001165989, 81001165997, 81001165999, 81001166000, 81001166015, 81001166073, 81001166090, 81001166094, 81001166098, 81001166109, 81001166119, 81001166124, 81001177755, 81001177759, 81001177764

Source

Official record: FDA (Device enforcement) ↗

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