Skip to content

Optima XR240amx

by GE Medical Systems, L.L.C.

Ref 5618704

Optima XR240amx is a device classified as Class IIb in the EU and Class II in the US made by GE Medical Systems, L.L.C., registered in EUDAMED on 15 Jul 2026 (Basic UDI-DI B-00840682122351), cleared under FDA 510(k) K162990 on 15 Nov 2016 and listed in FDA GUDID since 28 Jul 2017 (UDI-DI 00840682122351), active as of 24 Oct 2026. 2 FDA recalls are linked to it.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

2 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K162990

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00840682122351 Basic UDI-DI 00840682122351UDI-DIDate15 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00840682122351 UDI-DI Date28 Jul 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK162990 Date15 Nov 2016DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00840682122351 registered 15 Jul 2026 Active
  • FDA 510(k) K162990 decided 15 Nov 2016 Active
  • FDA GUDID UDI-DI 00840682122351 listed 28 Jul 2017 Listed

Recalls

2 recalls · 2 ongoing · FDA

    • Ongoing Z-2728-2026 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.

    • Ongoing Z-0813-2025 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.

Timeline

5 dated events

  1. Cleared FDA 510(k) K162990
  2. Listed FDA GUDID 00840682122351
  3. Recall initiated FDA recalls Z-0813-2025
  4. Recall initiated FDA recalls Z-2728-2026
  5. Registered EUDAMED B-00840682122351

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Optima XR240amx EUDAMED
Optima GUDID
Generic name
Mobile basic diagnostic x-ray system, digital
Model / reference
5618704 EUDAMED
XR240amx GUDID
Primary DI / UDI-DI
00840682122351
Basic UDI-DI
B-00840682122351
510(k) Number
FDA product code
IZL, MQB
EMDN code
Z11039016 Mobile radiographic units
GMDN term
Mobile basic diagnostic x-ray system, digital
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
892.1720, 892.1680
EU registration type
Legacy device (under a directive)
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
5618704
GUDID
XR240amx
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Mobile basic diagnostic x-ray system, digital

Cleared under the same submission (K162990)

Similar devices in this category

Other devices filed under MOBILE RADIOGRAPHIC UNITS.

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

  • NA SIGNA Bolt

    Class II

  • 6265300-60

    Class II

  • 6265300-62

    Class II

  • Photonova Spectra

    Class II

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

Properties

  • Prescription use
  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (19, all answered No)