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OptimaRecalls & reported problems across all models

GE Medical Systems, L.L.C. · 4 models in the FDA device registry

Data updated Oct 18, 2026 from official FDA records · Editorial policy

6 open recalls name at least one Optima model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls
6

We found 4 models of Optima by GE Medical Systems, L.L.C. in the FDA's device registry (GUDID). Together they are named in 1 adverse event report in the FDA's MAUDE database, 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).

6 FDA recall records name at least one of these models by its device identifier, 6 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Optima recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

  1. Jun 5, 2026Class IIOpen, 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-2728-2026 · Root cause: Process control · names 2 of these models · Recall details · FDA record ↗

  2. Jun 5, 2026Class IIOpen, 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 · Recall details · FDA record ↗

  3. Jun 5, 2026Class IIOpen, 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 · Recall details · FDA record ↗

  4. Nov 25, 2024Class IIOpen, 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-0813-2025 · Root cause: Component design/selection · Recall details · FDA record ↗

  5. Nov 25, 2024Class IIOpen, 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 · Recall details · FDA record ↗

  6. Nov 25, 2024Class IIOpen, 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 · Recall details · FDA record ↗

Most reported Optima problems

Device problems

  • Image Display Error/Artifact1

Patient problems

  • No Known Impact Or Consequence To Patient1

Optima models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

Recent Optima adverse event reports

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

Other GE Medical Systems, L.L.C. products

All GE Medical Systems, L.L.C. devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page