FDA Device recall Z-1819-2025

OEC Elite: The OEC Elite mobile C-arm is intended to provide fluoroscopic and digital spot images of the patient anatomy, interventional to…

FDA Device
Class II
ongoing
Published 2025-06-18

On 2025-06-18 the FDA classified a Class II recall of OEC Elite: The OEC Elite mobile C-arm is intended to provide fluoroscopic and digital spot images of the patient anatomy, interventional to… by Ge Medical Systems, citing OEC Elite and OEC 3D Mobile C-Arms Exceeding 4% Source to Image Distance in X-ray Field.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-1819-2025
Classification	Class II
Status	ongoing
Initiated	2025-03-21
Published	2025-06-18
Last updated	2026-09-13 11:57 UTC
Company	Ge Medical Systems
Distribution	n/a

Product

OEC Elite: The OEC Elite mobile C-arm is intended to provide fluoroscopic and digital spot images of the patient anatomy, interventional tools/devices, and contrast agents during diagnostic, interventional, and surgical procedures.

Reason

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

Identifiers

code_info	Two populations are potentially affected by this notification. 1. Listed in Appendix A - OEC Elite Mobile C-arm Systems… Two populations are potentially affected by this notification. 1. Listed in Appendix A - OEC Elite Mobile C-arm Systems (GTIN: 00001234567895) and OEC 3D Mobile C-arm Systems (GTIN: 00195278096944) that potentially have an X-ray field size greater than the 4% SID limit and do not contain the acceptance limit for the X-ray field size measurement in the System Service Manual. 2. Systems NOT listed in Appendix A - OEC Elite Mobile C-arm Systems (GTIN: 00001234567895) and OEC 3D Mobile C-arm Systems (GTIN: 00195278096944) that are within the allowed SID limit. However, the acceptance limit for the X-ray field size measurement is not stated in the System Service Manual. Appendix A Serial Numbers FAHXTX00002 FAHXTX00005 FAHXTX00014 FAHXTX00018 FAHXTX00019 FAHXTX00020 FAHXTX00024 FAHXTX00028 FAHXTX00034 FAHXTX00037 FAHXTX00043 FAHXTX00052 FAHXTX00063 FAHXTX00066 FAHXTX00068 FAHXTX00070 FAHXTX00075 FAHXTX00078 FAHXTX00079 FAHXTX00080 FAHXTX00081 FAHXTX00083 FAHXTX00092 FAHXTX00093 FAHXTX00097

code_info

Two populations are potentially affected by this notification. 1. Listed in Appendix A - OEC Elite Mobile C-arm Systems…

Two populations are potentially affected by this notification. 1. Listed in Appendix A - OEC Elite Mobile C-arm Systems (GTIN: 00001234567895) and OEC 3D Mobile C-arm Systems (GTIN: 00195278096944) that potentially have an X-ray field size greater than the 4% SID limit and do not contain the acceptance limit for the X-ray field size measurement in the System Service Manual. 2. Systems NOT listed in Appendix A - OEC Elite Mobile C-arm Systems (GTIN: 00001234567895) and OEC 3D Mobile C-arm Systems (GTIN: 00195278096944) that are within the allowed SID limit. However, the acceptance limit for the X-ray field size measurement is not stated in the System Service Manual. Appendix A Serial Numbers FAHXTX00002 FAHXTX00005 FAHXTX00014 FAHXTX00018 FAHXTX00019 FAHXTX00020 FAHXTX00024 FAHXTX00028 FAHXTX00034 FAHXTX00037 FAHXTX00043 FAHXTX00052 FAHXTX00063 FAHXTX00066 FAHXTX00068 FAHXTX00070 FAHXTX00075 FAHXTX00078 FAHXTX00079 FAHXTX00080 FAHXTX00081 FAHXTX00083 FAHXTX00092 FAHXTX00093 FAHXTX00097

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1819-2025%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.