Recall Z-1144-2023
Hologic, Inc. · initiated January 16, 2023
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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-3000-2D SDM-00001 SDM-SYS-9000-2D SDM-00001-M2D 3DM-SYS-STD 3DM-SYS-STD-NS SDM-05000-2AC SDM-05000-2A2 SDA-SYS-3000-3D SDA-SYS-3000-3D-UPS SDM-SYS-6000-3D-HTC SDM-05000-2D2 SDM-05000-3D2 SDM-SYS-6000-2D SDM-SYS-9000-3D
Codes / lots: 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…
Reason for recall
C-Arm unexpected movement may cause blunt trauma should the tube arm impinge upon an individual
FDA-determined cause: Device Design
Action taken
Hologic issued Urgent Medical Device Correction Letter customized to the customer on 01/16/23. Letter states reason for recall, health risk and action to take: We will schedule a service appointment and dispatch a field service engineer to visit your site to inspect your system and if necessary, make any corrections. " This will take approximately 6-14 hours to complete. " Until your service appointment, you will be able to continue to use your Selenia Dimensions or 3Dimensions system. If at any time during system operation, you observe any unanticipated error messages, or unexpected Carm movement, please discontinue use and contact Hologic's Technical Support immediately. Additionally, if you have any questions, please do not hesitate to reach out to Hologic's Technical Support at 1-877-371-4372 or breasthealth.support@hologic.com. Complete the on line Customer Confirmation Form using the link below within 3 business days of receiving this notice. Replying promptly will confirm your receipt of the notification and prevent you from receiving repeat notices. www.novasyte.com/hologic/selenia-dimensions-2022
Details
- Recall number
- Z-1144-2023
- Initiated
- January 16, 2023
- Posted by FDA
- February 21, 2023
- Product code
- OTE – Digital Breast Tomosynthesis
- Quantity
- 797 units
- Distribution
- US Nationwide distribution.
- Recalling firm
- Hologic, Inc., Danbury, CT