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U.S. Department of Health and Human Services

Class 2 Device Recall Centricity Universal Viewer 6.0,

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 Class 2 Device Recall Centricity Universal Viewer 6.0,see related information
Date Initiated by FirmAugust 30, 2018
Create DateOctober 18, 2018
Recall Status1 Terminated 3 on August 31, 2022
Recall NumberZ-0195-2019
Recall Event ID 81297
510(K)NumberK150420 
Product Classification System, image processing, radiological - Product Code LLZ
ProductCentricity 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
ActionOn 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 Commerce1
DistributionNY
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = LLZ
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