Hologic 3Dimensions/Selenia Dimensions Models: RM-SDM-00001-3D SDM-00001-2D SDM-00001-3D SDM-05000-3D3…
Medical device recall Z-1144-2023. Published in FDA’s Enforcement Report on Mar 1, 2023.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Mar 1, 2023. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 797 units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
C-Arm unexpected movement may cause blunt trauma should the tube arm impinge upon an individual
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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
797 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
UDI: 15420045508019; 15420045505636 Serial Numbers; 81001090068 81001100177 81001110594 81001110612 81001110627 81001121279 81001132051 81001132057 81001132096 81001142983 81001142990 81001142995 81001143035 81001143051 81001143060…
Every code shown here, 1,996 characters
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 81003154622 81003166319 81003166327 81003166337 81003166344 81003166357 81003166381 81003166406 81003166412 81003166413 81003166420 81003166435 81003177988 81003178012 81003178039 81003178050 81003178076 81003178078 81003178079 81003178106 81003178127 81004100226 81004110780 81004110782 81004121467 81004132251 81004132271 81004143293 81004143300 81004143311 81004143328 81004143337 81004143383 81004154645 81004154651 81004154657 81004154674 81004154697 81004154713 81004154721 81004154758 81004166448…
FDA’s list runs to 10,021 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
US Nationwide distribution.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Jan 16, 2023.
- FDA classified it on Feb 21, 2023.
- FDA’s Enforcement Report published it on Mar 1, 2023.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Hologic, Inc., of Danbury, CT.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 10,021 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.