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U.S. Department of Health and Human Services

Class 2 Device Recall Revolution EVO 3.6

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  Class 2 Device Recall Revolution EVO 3.6 see related information
Date Initiated by Firm May 24, 2018
Create Date July 31, 2018
Recall Status1 Terminated 3 on February 08, 2019
Recall Number Z-2584-2018
Recall Event ID 80484
510(K)Number K131576  
Product Classification System, x-ray, tomography, computed - Product Code JAK
Product Revolution EVO 3.6, labeled as
a. HVY WAUK;
b. LONG HINO;
c. LONG WAUK;
d. MID BJG;
e. MID WAUK.
Code Information a. HVY WAUK, Serial Number CJRBX1700130CN (System ID 770836EVO, UDI 01008406821097961117120021CJRBX1700130CN), Serial Number CJRBX1800005CN (System ID 918635REVO, UDI 01008406821097961118010021CJRBX1800005CN);   b. LONG HINO, Serial Number RE36A1800042YC (System ID 864560REV1, UDI 01008406821097961118020021RE36A1800042YC), Serial Number RE36A1800036YC (System ID 216448REVO, UDI 01008406821097961118020021RE36A1800036YC);   c. LONG WAUK, Serial Number CJRBX1800037CN (System ID 740383REVO, UDI 01008406821097961118040021CJRBX1800037CN),  Serial Number CJRBX1800022CN (System ID 317415REVO, UDI 01008406821097961118020021CJRBX1800022CN),  Serial Number CJRBX1800013CN (System ID 423844REVO, UDI 01008406821097961118010021CJRBX1800013CN),  Serial Number CJRBX1700132CN (System ID 719557REVO, UDI 01008406821097961117120021CJRBX1700132CN),  Serial Number CJRBX1800008CN (System ID 510248EVOCT, UDI 01008406821097961118010021CJRBX1800008CN);   d. MID BJG, Serial Number 500918HM8 (System ID 918623REVO, UDI Not Available), Serial Number CBCGG1700116HM (System ID 704834EVO, UDI 01008406821097961117120021CBCGG1700116HM), Serial Number CJRBX1800022CN (System ID 864560REVOL, UDI 01008406821097961118020021CJRBX1800022CN), Serial Number CBCGG1700097HM (System ID 979BRENCT1, UDI 01008406821097961117110021CBCGG1700097HM), Serial Number CBCGG1700094HM (System ID 405779REVO, UDI 01008406821097961117110021CBCGG1700094HM), Serial Number CBCGG1700107HM (System ID 217283HREVO, UDI 01008406821097961117110021CBCGG1700107HM), Serial Number CBCGG1700102HM (System ID 303SWDEVO, UDI 01008406821097961117110021CBCGG1700102HM), Serial Number CBCGG1700112HM (System ID 908788EVO, UDI 01008406821097961117120021CBCGG1700112HM),  Serial Number 490670HM7 (System ID 718226REVO, UDI Not Available);   e. MID WAUK, Serial Number CJRBX1800017CN (System ID 478454EVO, UDI 01008406821097961118020021CJRBX1800017CN), Serial Number CJRBX1800028CN (System ID 210MASHREVO, UDI 01008406821097961118030021CJRBX1800028CN), Serial Number CJRBX1800014CN (System ID 601968REVO, UDI 01008406821097961118010021CJRBX1800014CN). 
Recalling Firm/
Manufacturer		 GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact
800-437-1171
Manufacturer Reason
for Recall		 Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be properly wired to the partial system UPS (Uninteruptible Power Supply).
FDA Determined
Cause 2		 Component change control
Action GE Healthcare notified customers on about 05/24/2018 via URGENT MEDICAL DEVICE CORRECTION letter. The letter outlined the reason for recall and notified customers that a GE Healthcare representative would be contacting them to arrange for the correction of the devices. Any questions or concerns can be directed to GE Healthcare Service at 1-800-437-1171 or a local Service Representative.
Quantity in Commerce 42 units total
Distribution Nationwide distribution to AL, CA, CO, FL, IL, IN, MA, MD, MI, MS, NC, NJ, NY,OH, OK, SC, TN, TX, VA.
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 = JAK and Original Applicant = GE MEDICAL SYSTEMS, LLC
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