Optima XR200amxRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840682115278), received between Sep 23, 2019 and Sep 23, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Image Display Error/Artifact” (1 report).

2 FDA recall records name this device's identifier, 2 still open.

6 other recalls cover devices cleared under the same FDA submission (K142383); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Jun 5, 2026Open, Classified

   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.

   Z-2726-2026 · Root cause: Process control · FDA record ↗

2. Nov 25, 2024Open, Classified

   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.

   Z-0811-2025 · Root cause: Component design/selection · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2019Image Display Error/Artifact

  GE OPTIMA PORTABLE XR MACHINE STARTED DEVELOPING "BARCODE ARTIFACT" ON PATIENT IMAGES. IMAGES WERE STILL DIAGNOSTIC AS ARTIFACT WAS NOT OVER TISSUE OR BODY PART BUT ONLY IN FREE AIR AREAS OF EXPOSURE. INITIAL PHYSICS TESTING WAS ON SURVEY DATE PRIOR TO PATIENT USE AND ALL ITEMS DID PASS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9103363 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K142383. One submission often covers many models, so check the product and lot details in each record.

• Z-2727-2026 · Jun 5, 2026 · Open, Classified
  Optima XR220amx, Mobile Digital-Ready Radiographic System
• Z-0812-2025 · Nov 25, 2024 · Open, Classified
  GE Healthcare Optima XR220amx, Mobile Digital Radiographic System, Model Numbers: 1) 5555000-12; 2) 5555000-5; 3) 5555000-6; 4) A0659PB; 5) to be provided
• Z-0770-2016 · Dec 23, 2015 · Terminated
  GE Healthcare, Optima XR200amx, Mobile Digital Ready Radiographic System Designed to generate diagnostic radiographic images.
• Z-0768-2016 · Dec 23, 2015 · Terminated
  GE Healthcare, Optima XR220amx, Mobile Digital Ready Radiographic System Designed to generate diagnostic radiographic images.
• Z-1407-2015 · Dec 19, 2014 · Terminated
  GE Healthcare Automatic Mobile X-Ray (AMX) Series: Optima XR220 amx
• Z-1406-2015 · Dec 19, 2014 · Terminated
  GE Healthcare Automatic Mobile X-Ray (AMX) Series: Optima XR200 amx