| | Class 2 Device Recall OEC Elite |  |
| Date Initiated by Firm | November 21, 2024 |
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| Date Posted | December 18, 2024 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-0704-2025 |
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| Recall Event ID |
95846 |
| 510(K)Number | K170752 K171565 K172550 K192819 |
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| Product Classification |
Image-intensified fluoroscopic x-ray system, mobile - Product Code OXO
|
| Product | OEC Elite REF
Image-Intensified Fluoroscopic X-Ray System, Mobile. 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. |
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| Code Information |
Product Name: OEC Elite
GTIN code: 00001234567895
Lot/Serial Numbers / UDI codes:
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Recalling Firm/
Manufacturer |
GE OEC Medical Systems, Inc
384 N Wright Brothers Dr
Salt Lake City UT 84116-2862
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| For Additional Information Contact | GE HealthCare Service
800-437-1171 |
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Manufacturer Reason
for Recall | Due to manufacturing issue of insufficient sealing of X-ray tubes and can result in a potential oil leak and loss of fluoroscopic imaging capability. |
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FDA Determined
Cause 2 | Process control |
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| Action | On 11/21/2024, the firm sent an "URGENT MEDICAL DEVICE CORRECTION" Letter informing customers that GE HealthCare has become aware that recently manufactured OEC Elite and OEC 3D mobile C-arms, as well as recently replaced X-ray tubes on certain OEC Elite, OEC 3D and OEC 9900/OEC 9800 mobile C-arms potentially have insufficient sealing that can result in an oil leak. This issue could result in loss of fluoroscopic imaging capability.
Customers are instructed to:
1.Continue to use their OEC Elite, OEC 3D, OEC 9900 and/or OEC9800 mobile C-arm.
2.If oil is found leaking from the X-ray tube on their OEC Elite, OEC 3D, OEC9900 and/or OEC 9800 mobile C-arm, contact the local GE HealthCareService representative.
3.Ensure all potential users in their facility are made aware of this safety notification and the recommended actions.
4.Please complete and return the attached acknowledgement form torecall.15150@gehealthcare.com.
GE HealthCare will correct all affected products at no cost to you.
A GE HealthCare representative will contact you to plan and schedule for the inspection and correction if needed.
for any questions or concerns regarding this notification, please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative. |
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| Quantity in Commerce | 100 systems |
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| Distribution | U.S.: AK, AZ, CA, CO, CT, DC, FL, GA, Guam, HI, IA, ID, IL, IN, KS, KY, LA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY.
O.U.S.: Australia, Brazil, Canada, Chile, Costa Rica, India, Italy, Philippines, Poland, Portugal, Sweden, Switzerland, and United Kingdom |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| 510(K) Database | 510(K)s with Product Code = OXO
510(K)s with Product Code = OXO
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