Optima XR220amxRecalls & reported problems

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

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-2727-2026 · 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-0812-2025 · Root cause: Component design/selection · FDA record ↗

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-2726-2026 · Jun 5, 2026 · Open, Classified
  Optima XR200amx, Mobile Digital-Ready Radiographic System
• Z-0811-2025 · Nov 25, 2024 · Open, Classified
  GE Healthcare Optima XR200amx, Mobile Digital Radiographic System, Model Numbers: 1) 5555000-3; 2) 5555000-4: 3) A0659MB
• 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-1406-2015 · Dec 19, 2014 · Terminated
  GE Healthcare Automatic Mobile X-Ray (AMX) Series: Optima XR200 amx
• Z-1407-2015 · Dec 19, 2014 · Terminated
  GE Healthcare Automatic Mobile X-Ray (AMX) Series: Optima XR220 amx