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Na 5777746

by GE Medical Systems, L.L.C.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

3 ongoing

This device is named in the recall

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00840682144209 UDI-DI Date21 Dec 2018ListedStatusListed GUDID: in commercial distribution

Recalls

7 recalls · 3 ongoing · FDA

  • 3 recalls, same reason

    • Ongoing Z-1746-2019 FDA Class II initiated 12 Feb 2019
    • Ongoing Z-1749-2019 FDA Class II initiated 12 Feb 2019
    • Ongoing Z-1750-2019 FDA Class II initiated 12 Feb 2019

    GE Healthcare PET/CT Table Stop Without Stopping X-Ray Exposure

    • Terminated Z-2580-2018 FDA Class II initiated 24 May 2018

    Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be properly wired to the partial system UPS (Uninteruptible Power Supply).

    • Terminated Z-2579-2018 FDA Class II initiated 24 May 2018

    DIGITAL ReadyCT/PET systems recently installed with a GE supplied A! electrical panel may not be properly wired to the partial system UPS (Uninteruptible Power Supply).

  • 2 recalls, same reason

    • Terminated Z-2191-2017 FDA Class II initiated 19 May 2017
    • Terminated Z-2193-2017 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.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Generic Name
PET system
Model / Reference
5777746
Primary DI / UDI-DI
00840682144209
510(k) Number
FDA Product Code
JAK, KPS
GMDN Term
PET system
Device Class
Class II
Regulation Number
892.1750, 892.1200
GUDID distribution status
In Commercial Distribution

Related devices

Category: Full-body CT systemPET system

Cleared under the same submission (K133657)

Cleared under the same submission (K161574)

Other devices from GE Medical Systems, L.L.C.

See all devices from GE Medical Systems, L.L.C. →

Properties

  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (11)

  • 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
  • Lot / Batch Number: No
  • Expiration Date: No