OEC 9800 REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The Series OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. Clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures.
- Company
- Ge Oec Medical Systems, Inc
- Recall Initiated
- November 21, 2024
- Posted
- December 18, 2024
- Recall Number
- Z-0706-2025
- Quantity
- 25 systems
- Firm Location
- Salt Lake City, UT
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.
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
Lot / Code Info
Product Name: OEC 9800 GTIN code: 00840682114349 Lot/Serial Numbers / UDI codes: 82XXXX04237 (01)00840682114349(11)170600(21)82XXXX04237 8S-2249 Not Applicable-MFG date prior to UDI compliance requirement 89-1022 Not Applicable-MFG date prior to UDI compliance requirement 82-1772 Not Applicable-MFG date prior to UDI compliance requirement 82-0980 Not Applicable-MFG date prior to UDI compliance requirement 8S-1793 Not Applicable-MFG date prior to UDI compliance requirement 82-2349 Not Applicable-MFG date prior to UDI compliance requirement 82-3361 Not Applicable-MFG date prior to UDI compliance requirement 8S-1398 Not Applicable-MFG date prior to UDI compliance requirement 82-0908 Not Applicable-MFG date prior to UDI compliance requirement 82-0599 Not Applicable-MFG date prior to UDI compliance requirement 8S-0533 Not Applicable-MFG date prior to UDI compliance requirement 82-0189 Not Applicable-MFG date prior to UDI compliance requirement 8S-0186 Not Applicable-MFG date prior to UDI compliance requirement 89-2415 Not Applicable-MFG date prior to UDI compliance requirement 8S-3259 Not Applicable-MFG date prior to UDI compliance requirement 8S-3426 Not Applicable-MFG date prior to UDI compliance requirement 89-1530 Not Applicable-MFG date prior to UDI compliance requirement 82-2955 Not Applicable-MFG date prior to UDI compliance requirement 8S-0958-RC Not Applicable-MFG date prior to UDI compliance requirement 82-1154 Not Applicable-MFG date prior to UDI compliance requirement 8S-3032 Not Applicable-MFG date prior to UDI compliance requirement 8S-3145 Not Applicable-MFG date prior to UDI compliance requirement 89-1916-RC Not Applicable-MFG date prior to UDI compliance requirement 82-4134 Not Applicable-MFG date prior to UDI compliance requirement
Root Cause
Process control
Action Taken
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.