Date Initiated by Firm |
August 30, 2018 |
Create Date |
October 18, 2018 |
Recall Status1 |
Terminated 3 on August 31, 2022 |
Recall Number |
Z-0195-2019 |
Recall Event ID |
81297 |
510(K)Number |
K150420
|
Product Classification |
System, image processing, radiological - Product Code LLZ
|
Product |
Centricity Universal Viewer with Cross Enterprise Display This impacts product versions 6.0 SP1 and higher. |
Code Information |
SYSTEM ID: 315470CPUWPV UDI #: 8406821038 00DE #: 2090255-001 |
Recalling Firm/ Manufacturer |
GE Healthcare, LLC 3000 N Grandview Blvd Waukesha WI 53188-1615
|
For Additional Information Contact |
262-312-7277
|
Manufacturer Reason for Recall |
Remote comparison studies displayed may be associated with the wrong patient, without a caution icon present.
|
FDA Determined Cause 2 |
Component design/selection |
Action |
On August 30, 2018, GE Healthcare sent Urgent Medical Device Correction letters to customers with affected units. GE Healthcare will correct all affected products at no cost to you. A GE Healthcare representative will contact you to arrange for the correction. 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 |
1 |
Distribution |
NY |
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 = LLZ and Original Applicant = GE HEALTHCARE
|