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Open, Classified

OEC 3D

FDA Recall Z-1820-2025 · Posted 2025-06-09

Recalling FirmGE Medical Systems, LLC
Recall StatusOpen, Classified
Product CodeOXO
Date Initiated2025-03-21
Product QuantityTotal for both products: 3472 (2,919 US; 553 OUS)

Reason for Recall

OEC Elite and OEC 3D Mobile C-Arms Exceeding 4% Source to Image Distance in X-ray Field.

Firm Action

All impacted customers with receive a customer letter notifying them of the potential issue. GE HealthCare will send a field service engineer to perform measurements of the Xray field on the identified systems (listed in Appendix A of the customer letter).

Root Cause

Process control

Distribution Pattern

US and OUS

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K233669OEC 3DGe Oec Medical Systems, Inc. · 2024-03-28K203346OEC 3DGe Oec Medical Systems, Inc. · 2021-03-05

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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