Hologic 3Dimensions/Selenia Dimensions Models: RM-SDM-00001-3D SDM-00001-2D SDM-00001-3D SDM-05000-3D3 SDM-05000-2DC SDM

FDA device recall Z-1144-2023 · posted 2023-02-21 · Open, Classified

Recall details

Recalling firm

Hologic, Inc.

Reason for recall

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

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

Root cause

Device Design

Status

Open, Classified

Product code

OTE

Quantity affected

797 units

Distribution

US Nationwide distribution.

Date initiated

2023-01-16

Date posted

2023-02-21

Location

Danbury, CT