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Envision SmartCurve Paddle License

by Hologic United States GUDID

Product code OTE

Regulatory status

as of 25 Oct 2026

Recall ongoing. 3 ongoing FDA recalls. See recalls

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number15420045515895 UDI-DIDate9 Oct 2026ListedStatusIn distribution

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • 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 · synced 23 Oct 2026

Trade Name
Envision
Generic Name
Stationary mammographic x-ray system, digital
Model / Ref / Catalog
Envision SmartCurve Paddle License, CMP-01924
Primary DI / UDI-DI
15420045515895
PMA Number
FDA Product Code
OTE
GMDN Term
Stationary mammographic x-ray system, digital
Device Class
Class III
Commercial Distribution
In Commercial Distribution

Related devices

Cleared under the same submission (P080003)

Show all (12)

Other devices from Hologic

See all devices from Hologic →

Properties & raw data

Show properties, registry sources and raw records
  • Prescription Use
  • Lot / Batch Number
Other properties (12)
  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No

Sources (1)

  • FDA UDI ef2194e5-9c82-4857-bc4c-5e30ed800589 36 fields · synced 23 Oct 2026