| Class 2 Device Recall Centricity Universal Viewer | |
Date Initiated by Firm | May 16, 2019 |
Date Posted | July 01, 2019 |
Recall Status1 |
Terminated 3 on April 14, 2023 |
Recall Number | Z-1910-2019 |
Recall Event ID |
82998 |
510(K)Number | K150420 K182419 |
Product Classification |
System, image processing, radiological - Product Code LLZ
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Product | Centricity Universal Viewer 6.0
Is a device that displays medical images and data from various imaging sources, and from other healthcare information sources. |
Code Information |
UDI # 840682103800 Model # 2098249-002 Software Version: 6.0.9, 6.0SP9.01, CPACS 6.0 SP9.0.1, UV 6.0 SP9.0.1, UV 6.0 SP9.01.1, UV 6.0 SP9.0.1.2, UV 6.0 SP9.01.3, UV6.0 SP9.01.4, UV 6.0 SP9.01.5, UV 6.0 SP9.0.1.6, UV Version 6.0 SP5.0.4.1, UV Version 6.0 SP9, UV Version 6.0 SP9.0.0.1, UV Version 6.0 SP901, UV Version 6.0 SP9011, and UV Version 6.0 SP902 |
Recalling Firm/ Manufacturer |
GE Healthcare, LLC 3000 N Grandview Blvd Waukesha WI 53188-1615
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For Additional Information Contact | GE Healthcare Service 800-4371171 |
Manufacturer Reason for Recall | There is the possibility of viewing studies directly from the Enterprise Archive or VNA with incorrect patient images because the updated series or study is not present in the archive. |
FDA Determined Cause 2 | Device Design |
Action | On May 20, 2019, the firm, GE Healthcare, sent an " URGENT MEDICAL DEVICE CORRECTION" letter date 5/20/2019 to their consignees. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: discontinue use of the UV study management functionality for study split/study info updates until a correction is available and to wait for a GE representative to contact them 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 | 145 (87 US 103 OUS) |
Distribution | Worldwide Distribution: US (nationwide) to states of: FL, GA, IL, IN, LA, MA, MO, NJ, NY, OR, PA, SC, SD, TX, and WA; and countries of : Brazil, Canada, Chile, France, French Polynesia, Germany, India, Italy, Japan, Kuwait, Lebanon, Singapore, Spain and United Kingdom. |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = LLZ
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