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Na 5421698

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

4 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 Number00840682119658 UDI-DI Date1 Aug 2016ListedStatusListed GUDID: in commercial distribution

Recalls

8 recalls · 4 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-2727-2026 FDA Class II initiated 5 Jun 2026
    • Ongoing Z-2726-2026 FDA Class II initiated 5 Jun 2026

    GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional testing of the safety pawl may not have been performed to confirm proper assembly. If a failure of the internal counterpoise cable occurs, the Column Safety mechanism will not work, causing the arm with X-ray tube and collimator to drop downward on the column track. This could result in patient injury during an exam.

  • 2 recalls, same reason

    • Ongoing Z-0811-2025 FDA Class II initiated 25 Nov 2024
    • Ongoing Z-0812-2025 FDA Class II initiated 25 Nov 2024

    GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement performed, some bolts used in the Column Safety mechanism can be missing. If these bolts are missing and a failure of the internal counterpoise cable occurs, the Column Safety mechanism will not work properly causing the arm with X-ray tube and collimator to drop downward on the column track.

  • 2 recalls, same reason

    • Terminated Z-0770-2016 FDA Class II initiated 23 Dec 2015
    • Terminated Z-0768-2016 FDA Class II initiated 23 Dec 2015

    Potential safety latch mechanism failure. The safety latch, within the column that supports the horizontal arm, is a backup in the unlikely event the primary safety cable breaks. A fall of the arm assembly could result in bodily harm to a person.

  • 2 recalls, same reason

    • Terminated Z-1407-2015 FDA Class II initiated 19 Dec 2014
    • Terminated Z-1406-2015 FDA Class II initiated 19 Dec 2014

    An issue was identified with the mAs accuracy check performed on the system that could result in inaccuracies in the 10% to 20% range for exposure times longer than 15 msec.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Generic Name
Mobile basic diagnostic x-ray system, digital
Model / Reference
5421698
Primary DI / UDI-DI
00840682119658
510(k) Number
FDA Product Code
IZL
GMDN Term
Mobile basic diagnostic x-ray system, digital
Device Class
Class II
Regulation Number
892.1720
GUDID distribution status
In Commercial Distribution

Related devices

Category: Mobile basic diagnostic x-ray system, digital

Cleared under the same submission (K142383)

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