Optima XR200amx

• FDA 510(k) K142383 decided 25 Sep 2014 Active
• FDA GUDID UDI-DI 00840682115278 listed 1 Aug 2016 Listed

• 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.

1. 25 Sep 2014 Cleared FDA 510(k) K142383
2. 19 Dec 2014 Recall initiated FDA recalls Z-1407-2015
3. 19 Dec 2014 Recall initiated FDA recalls Z-1406-2015
4. 23 Dec 2015 Recall initiated FDA recalls Z-0770-2016
5. 23 Dec 2015 Recall initiated FDA recalls Z-0768-2016
6. 1 Aug 2016 Listed FDA GUDID 00840682115278
7. 25 Nov 2024 Recall initiated FDA recalls Z-0811-2025
8. 25 Nov 2024 Recall initiated FDA recalls Z-0812-2025
9. 5 Jun 2026 Recall initiated FDA recalls Z-2727-2026
10. 5 Jun 2026 Recall initiated FDA recalls Z-2726-2026

Trade name

Optima

Generic name

Portable basic diagnostic x-ray system, digital

Model / reference

XR200amx

Primary DI / UDI-DI

00840682115278

510(k) Number

K142383 ↗

FDA product code

IZL

GMDN term

Portable basic diagnostic x-ray system, digital

Device class

Class II

Regulation number

892.1720

GUDID distribution status

In Commercial Distribution

Category: Portable basic diagnostic x-ray system, digital

Other devices filed under FDA product code IZL (System, x-ray, mobile).

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• REPLACEMENT BATERY FOR GE AMX-4 PORT. X-RAY MACH. by Portable Power Systems, Inc.
• DRGEM TOPAZ-40D by DRGEM Corporation
• DRX-Revolution Nano Mobile X-ray System by CARESTREAM HEALTH, INC.
• BATTERY PACK by Portable Power Systems, Inc.
• SCD-105 AND SCD-125 CAPACITOR DISCHARGE MOBILE X-R by Acoma Medical Imaging, Inc.
• CAP-MOBILE by Philips Medical Systems (Cleveland), Inc.

• NA SIGNA Bolt

  Class II

  FDA 510(k) K253780 Active Cleared 6 Feb 2026 GUDID on market

• 6265300-60

  Class II

  GUDID on market

• 6265300-62

  Class II

  GUDID on market

• Photonova Spectra

  Class II

  CE/MDR FDA 510(k) K253520 Active Cleared 20 Mar 2026 +1authorizations

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