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U.S. Department of Health and Human Services

Class 2 Device Recall GE Healthcare RFX

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  Class 2 Device Recall GE Healthcare RFX see related information
Date Initiated by Firm November 21, 2016
Create Date December 23, 2016
Recall Status1 Terminated 3 on September 26, 2017
Recall Number Z-0915-2017
Recall Event ID 75851
510(K)Number K760466  
Product Classification Table, radiographic, tilting - Product Code IXR
Product RFX

Code Information  Mfg. Lot or Serial # System ID Not Available 818963RM4 00000026176YY8 213266SFX Not Available 209384MMRF 00000047956YY8 INSIGHTXR010 Not Available 818891VA1 Not Available 818891VA2 Not Available 2025761X46 Not Available 2025761X40 Not Available 813633RFX Not Available 813971RF6 Not Available 708259NWRF7 00000034249YY3 913596PR4 00000023702YY4 606327ADV Not Available 504867LRF2 Not Available 318388RF3 00000023806YY3 617735B6 00000022210YY9 313576RM1663 00000022218YY2 313576RM3622 Not Available 313576RM3645 Not Available 218726SMRF2 Not Available 601865RF1 Not Available 601865RF2 Not Available 601376OP3 Not Available 919681DB3 Not Available 919250WM9 00000026194YY1 706791D7 Not Available 914964SJRF 00000071239YY8 405271PRF4 00000022200YY0 215576RF18 00000128622MO8 615871SRF1 Not Available 817965HADV Not Available 713364W03 Not Available 206244RM2 00000022207YY5 EG1055VA01 00000022140YY8 SK1005RX05 00000023856YY8 AE1020RX01 
Recalling Firm/
GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact Stephanie Cass
Manufacturer Reason
for Recall
GE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2, Prestilix, Prestige VH, Prestige SI, RFX/SFX, Legacy, Precision 500D, ADVANTX and Innova 2000 systems.
FDA Determined
Cause 2
Nonconforming Material/Component
Action Consignees were sent on 11/21/2016 a GE Healthcare "Urgent Medical Device Correction" letter GEHC Ref# FMI 10913 dated November 21, 2016. The letter was addressed to Director of Radiology, Risk Manager/Hospital Administrator, and Director of Biomedical Engineering. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
Quantity in Commerce Total for all products 1,598 (USA 824, OUS 774)
Distribution US: AL, AR, AZ, CA, CO, CT, DC, FL, GA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT,NC, NE NH, NJ, NM, NY, NV, OH, OK, PA, RI, SC, SD, TN, TX,, VA, WA, WO, WY, WV. OUS: Algeria Armenia Australia Austria Brazil Canada Chile China Denmark Egypt France Germany Guatemala Honduras Hong Kong Hungary Iceland India Ireland Italy Japan Korea Libya Mexico Netherlands Netherlands Peru Poland Portugal Russia Saudi Arabia Serbia Sierra Leone Slovakia Spain Taiwan Thailand Turkey United Arab Emirates United Kingdom Venezuela Vietnam
Total Product Life Cycle TPLC Device Report

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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = IXR and Original Applicant = GENERAL ELECTRIC CO.