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U.S. Department of Health and Human Services

Class 2 Device Recall Silhouette VR

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  Class 2 Device Recall Silhouette VR see related information
Date Initiated by Firm March 29, 2019
Date Posted June 10, 2019
Recall Status1 Terminated 3 on April 15, 2021
Recall Number Z-1755-2019
Recall Event ID 82668
510(K)Number K982955  
Product Classification System, x-ray, stationary - Product Code KPR
Product Silhouette VR

This fully integrated system offers intuitive controls with advanced applications for maximum performance all in a space-saving design.
Code Information DZ1061RX02 and UP389014.
Recalling Firm/
GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact GE Healthcare Service
Manufacturer Reason
for Recall
There has been a reported incident of a Distar CRT monitor that has fallen off the monitor wall mount related to product aging.
FDA Determined
Cause 2
Device Design
Action On March 29, 2019, GE Healthcare sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated March 29, 2019 to its consignees/customers. The letter described the product, problem and actions to be taken. Customers were instructed to do the following: Please follow the precautions below until the monitor feet on your unit are replaced: -The CRT monitor and suspension should be inspected and used with caution. Make sure the monitors are secured properly to the tray before each use. -Immediately stop using the system if any looseness of the monitor is noticed and contact your GE service representative. -Monitor should not be positioned directly above the patient. -Before service or preventative maintenance of the monitor is attempted, review the service and preventive maintenance procedures. Also the customer were instructed to complete and return the MEDICAL DEVICE NOTIFICATION ACKNOWLEDGEMENT RESPONSE REQUIRED form by scanning or taking a photo of the completed form e-mailing to: Recall_10927_reply_form@ge.com. F/U visits by GE Healthcare will be made to replace the plastic feet. 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 825 (38 US and 787 OUS) in total
Distribution Worldwide Distribution: US (nationwide) to states of: AL, CA, CT, FL, GA, HI, IL, LA, MD, MI, MN, MO, NH, NY, OK, PA, TN, and VA; and countries of: Algeria, Argentina, Belgium, Bosnia & Herzegovina, Brazil, Bulgaria, Canada, China, Costa Rica, Cote D'Ivoire, Cyprus, Czech Republic, Egypt , France, French Polynesia, Germany, Greece, Guadeloupe, Guyana, Hungary, Italy, Japan, Korea, Lebanon, Mexico, Morocco, New Caledonia, Norway , Poland, Portugal, Russia, Saudi Arabia,Slovakia, Spain, Taiwan, Tunisia, Turkey, Ukraine, United Kingdom, Venezuela, and 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 = KPR and Original Applicant = GE MEDICAL SYSTEMS