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Selenia® Dimensions® ASY-08483-2D-CN

by Hologic GUDID

Listed (no authorization) FDA GUDID database listing only

Regulatory status

as of 26 Oct 2026

Recall ongoing. 3 ongoing FDA recalls. See recalls

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number15420045518230 UDI-DIDate12 Mar 2026ListedStatusIn distribution

Coverage

1 jurisdiction

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  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — GUDID listing Listed

Recalls

4 recalls · 3 ongoing · FDA

    • Ongoing Z-2168-2026 FDA Class II initiated 8 Apr 2026

    Complaints have been received of systems developing loose, missing, or broken internal bolts over time.

    • Ongoing Z-3248-2024 FDA Class II initiated 19 Aug 2024

    Identified an issue with Selenia Dimensions 1.12.0 and 3Dimensions 2.3.0 system software when used in combination with C-View software in which the quality of the final C-View synthesized 2D image is impacted and may appear blurry and result in misdiagnosis with the possibility being a false negative diagnosis

    • Ongoing Z-1144-2023 FDA Class II initiated 16 Jan 2023

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

    • Terminated Z-1343-2020 FDA Class II initiated 21 Jan 2020 via P080003, on the same PMA

    The recalling firm has received reports from the field of the C-arm on the Selenia Dimensions system seizing or dropping during field repairs and cleaning of the systems.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

Specification

GUDID

Trade Name
Selenia® Dimensions®
Generic Name
Stationary mammographic x-ray system, digital
Model / Ref / Catalog
ASY-08483-2D-CN
Primary DI / UDI-DI
15420045518230
PMA Number
FDA Product Code
OTE
GMDN Term
Stationary mammographic x-ray system, digital
Commercial Distribution
In Commercial Distribution

Related devices

Cleared under the same submission (P080003)

Show all (12)

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