Z-2168-2026Class II

3DIMENSIONS MAMMOGRAPHY SYSTEM; Model Numbers: 3DM-SYS-INTL2D, 3DM-SYS-INTL2D-MOB, 3DM-SYS-INTL2D-NS...

Name: Z-2168-2026 3DIMENSIONS MAMMOGRAPHY SYSTEM; Model Numbers: 3DM-SYS-INTL2D, 3DM-SYS-INTL2D-MOB, 3DM-SYS-INTL2D-NS...
Creator: Hologic, Inc
Published: 2026-04-08
License: https://open.fda.gov/license/

Hologic, Inc. / initiated 2026-04-08 / Open, Classified / root cause: design

FDA source

Hologic, Inc began a recall of 3DIMENSIONS MAMMOGRAPHY SYSTEM; Model Numbers: 3DM-SYS-INTL2D, 3DM-SYS-INTL2D-MOB, 3DM-SYS-INTL2D-NS, 3DM-SYS-INTL3D, 3DM-SYS-INTL3D-MOB, 3DM-SYS-INTL3D-NS... on 2026-04-08. FDA classified it as Class II and gives the reason as "Complaints have been received of systems developing loose, missing, or broken internal bolts over time". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2168-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-04-08
Posted: 2026-05-12
Recalling firm: Hologic, Inc.
Product: 3DIMENSIONS MAMMOGRAPHY SYSTEM; Model Numbers: 3DM-SYS-INTL2D, 3DM-SYS-INTL2D-MOB, 3DM-SYS-INTL2D-NS, 3DM-SYS-INTL3D, 3DM-SYS-INTL3D-MOB, 3DM-SYS-INTL3D-NS, 3DM-SYS-STD, 3DM-SYS-STD-MOB, 3DM-SYS-STD-NS.
Product code: OTE Digital Breast Tomosynthesis
Reason for recall: Complaints have been received of systems developing loose, missing, or broken internal bolts over time.
Root cause tag: design
FDA root cause: Device Design
Action: On April 8, 2026 URGENT FIELD SAFETY NOTICE letters were sent to customers. Customers were informed of implementing an updated recurring maintenance inspection for detecting loosened, missing, or broken bolts within the VTA. Hologic Service will reach out to schedule your service appointment and perform the required inspection. Following the initial inspection, recurring inspections are required to be conducted at least every 6 months to ensure continued safe/proper operation of the system. Future inspections will consist of torque and visual confirmation that all bolts are present and that there is no indication of loosening. Actions: You may continue to use your 3Dimensions or Selenia Dimensions for its intended use. If at any time during system operation, you observe unexpected C-Arm movement, please discontinue use and contact Hologic s Technical Support immediately. Report suspected device complaints and/or adverse events to Hologic and the FDA (contact details below). After initial inspection by Hologic, it is required to have the inspection performed at least every 6 months as well as the other defined maintenance and service activities which are critical for continued safe and effective operation of the Selenia Dimensions or 3Dimensions system. Forward this notice to anyone in your facility that needs to be informed. Post a copy of this notice in a visible area near the affected devices where operators can view for awareness and please keep a copy for your records.
Quantity in commerce: 14837 units
Distribution: US Nationwide distribution.
Product codes and lots: "[Model No.; UDI]: [3DM-SYS-INTL2D;15420045510609], [3DM-SYS-INTL2D-MOB;15420045510593], [3DM-SYS-INTL2D-NS;15420045510586], [3DM-SYS-INTL3D;15420045510579], [3DM-SYS-INTL3D-MOB;15420045510562], [3DM-SYS-INTL3D-NS;15420045510555], [3DM-SYS-STD;15420045510524], [3DM-SYS-STD-MOB;15420045510531], [3DM-SYS-STD-NS;15420045510548]; All Serial No.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2168-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2167-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-05-20	2026-05-12
Z-2168-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-05-20	2026-05-12

Product code OTE

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)