FDA Medical devices recall ·
OEC 3D recall
- Recall number
- Z-1820-2025
- Date
- (initiated March 21, 2025)
- Company / brand
- GE Medical Systems, LLC
3000 N Grandview Blvd, Waukesha, WI, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- Total for both products: 3472 (2,919 US; 553 OUS)
- Initiated by
- FDA Mandated
Read the official FDA notice ↗
Product
OEC 3D
Why was it recalled?
OEC Elite and OEC 3D Mobile C-Arms Exceeding 4% Source to Image Distance in X-ray Field.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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 FAHXTX00110 FAHXTX00111 FAHXTX00112 FAHXTX00114 FAHXTX00115 FAHXTX00116 FAHXTX00117 FAHXTX00118 FAHXTX00119 FAHXTX00120 FAHXTX00121 FAHXTX00122 FAHXTX00124 FAHXTX00125 FAHXTX00135 FAHXTX00137 FAHXTX00138 FAHXTX00151 FAHXTX00152 FAHXTX00155 FAHXTX00156 FAHXTX00162 FAHXTX00163 FAHXTX00166 FAHXTX00170 FAHXTX00171 FAHXTX00177 FAHXTX00178 FAHXTX00188 FAHXTX00192 FAHXTX00193 FAHXTX00202 FAHXTX00204 FAHXTX00211 FAHXTX00212 FAHXTX00217 FAHXTX00219 FAHXTX00220 FAHXTX00221 FAHXTX00222 FAHXTX00223 FAHXTX00
Distribution
US and OUS
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1820-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.