| Class 2 Device Recall GE Healthcare Advantx LCN |  |
Date Initiated by Firm | November 21, 2016 |
Create Date | December 23, 2016 |
Recall Status1 |
Terminated 3 on September 26, 2017 |
Recall Number | Z-0907-2017 |
Recall Event ID |
75851 |
510(K)Number | K974367 |
Product Classification |
System, x-ray, angiographic - Product Code IZI
|
Product | ADVANTX LCN+ |
Code Information |
Mfg. Lot or Serial # System ID 00000089619MO1 205592MLC 00000089632MO4 205592MLC 00000052196YY3 601459LC 00000023729YY7 910343NHC1 00000031441YY9 603668CLC3 00000034211YY3 603668CLC3 00000034271YY7 973429CATH Not Available 215576LC2 Not Available 610250SC Not Available 0910062022 Not Available 0910062022 00000023777YY6 1025 00000026231YY1 3919-1 00000023841YY0 93162 00000023841YY0 93162 Not Available GOLD000540 |
Recalling Firm/ Manufacturer |
GE Healthcare, LLC 3000 N Grandview Blvd Waukesha WI 53188-1615
|
For Additional Information Contact | Stephanie Cass 800-437-1171 |
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 = IZI
|
|
|
|