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CZT Upgrade H3906DE

by GE Medical Systems Israel, Functional Imaging

CZT Upgrade H3906DE is a Class II device made by GE Medical Systems Israel, Functional Imaging, cleared under FDA 510(k) K153402 on 21 Jan 2016 and listed in FDA GUDID since 15 May 2018 (UDI-DI 00840682141635), active as of 23 Oct 2026. 6 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

510(k) K153402

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00840682141635 UDI-DI Date15 May 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK153402 Date21 Jan 2016DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K153402 decided 21 Jan 2016 Active
  • FDA GUDID UDI-DI 00840682141635 listed 15 May 2018 Listed

Recalls

6 recalls · 1 ongoing · FDA

    • Ongoing Z-1057-2023 FDA Class I initiated 19 Dec 2022

    A mitigation may not be correctly implemented. If this is the case, the detector can fall, leading to life-threatening bodily injury.

    • Terminated Z-0855-2021 FDA Class II initiated 10 Dec 2020

    GE Healthcare has become aware that rotor bearing screws were found loose on one detector in the field, leading to the release of one of the four rotor bearings in the detector.

    • Terminated Z-2993-2020 FDA Class II initiated 14 Aug 2020

    Rotor bearing screws were found loose on detector.

  • 2 recalls, same reason

    • Terminated Z-1258-2019 FDA Class II initiated 20 Mar 2019
    • Terminated Z-1264-2019 FDA Class II initiated 20 Mar 2019

    During installation of certain Nuclear Medicine systems delivered with dismounted detectors, some detector screws may not have been secured correctly, leading to the possible loss of one detector mounting design redundancy.

    • Terminated Z-2195-2017 FDA Class II initiated 19 May 2017

    It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.

Timeline

8 dated events

  1. Cleared FDA 510(k) K153402
  2. Recall initiated FDA recalls Z-2195-2017
  3. Listed FDA GUDID 00840682141635
  4. Recall initiated FDA recalls Z-1258-2019
  5. Recall initiated FDA recalls Z-1264-2019
  6. Recall initiated FDA recalls Z-2993-2020
  7. Recall initiated FDA recalls Z-0855-2021
  8. Recall initiated FDA recalls Z-1057-2023

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
CZT Upgrade
Generic name
Full-body CT system
Model / reference
H3906DE
Primary DI / UDI-DI
00840682141635
510(k) Number
FDA product code
KPS, JAK
GMDN term
Full-body CT system
Device class
Class II
Regulation number
892.1200, 892.1750
GUDID distribution status
In Commercial Distribution

Related devices

Category: Full-body CT systemStationary gamma camera system

Cleared under the same submission (K153402)

and 2 more cleared under K153402

Other devices from GE Medical Systems Israel, Functional Imaging

See all devices from GE Medical Systems Israel, Functional Imaging →

Properties

  • Prescription use
  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (11, all answered No)