Reported Mar 1, 2023 · Ongoing

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

Hologic, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Hologic, Inc. · 36 Apple Ridge Rd · Danbury, CT · 06810-7301

Is this the product you have?

  • 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
Lot codes and dates
  • UDI15420045508019; 15420045505636 Serial Numbers;

    802 of 802 codes

    • 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
Amount recalled
797 units

Where it was sold

  • Nationwide

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:55 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.