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Optima XR220amx

by GE Medical Systems, L.L.C.

Optima XR220amx is a Class II device made by GE Medical Systems, L.L.C., cleared under FDA 510(k) K142383 on 25 Sep 2014 and listed in FDA GUDID since 1 Aug 2016 (UDI-DI 00840682115261), active as of 23 Oct 2026. 8 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

4 ongoing

This device is named in the recall

Documents

510(k) K142383

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 Number00840682115261 UDI-DI Date1 Aug 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK142383 Date25 Sep 2014DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K142383 decided 25 Sep 2014 Active
  • FDA GUDID UDI-DI 00840682115261 listed 1 Aug 2016 Listed

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.

Timeline

10 dated events

  1. Cleared FDA 510(k) K142383
  2. Recall initiated FDA recalls Z-1407-2015
  3. Recall initiated FDA recalls Z-1406-2015
  4. Recall initiated FDA recalls Z-0770-2016
  5. Recall initiated FDA recalls Z-0768-2016
  6. Listed FDA GUDID 00840682115261
  7. Recall initiated FDA recalls Z-0811-2025
  8. Recall initiated FDA recalls Z-0812-2025
  9. Recall initiated FDA recalls Z-2727-2026
  10. Recall initiated FDA recalls Z-2726-2026

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Optima
Generic name
Mobile basic diagnostic x-ray system, digital
Model / reference
XR220amx
Primary DI / UDI-DI
00840682115261
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)

Similar devices in this category

Other devices filed under Mobile basic diagnostic x-ray system, digital.

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Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)