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U.S. Department of Health and Human Services

Class 2 Device Recall GE BRIGHTSPEED DELIGHT CT SCANNER SYSTEM

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 Class 2 Recall
GE BRIGHTSPEED DELIGHT CT SCANNER SYSTEM
see related information
Date Posted May 19, 2011
Recall Status1 Terminated on July 10, 2012
Recall Number Z-2214-2011
Recall Event ID 57591
Premarket Notification
510(K) Number
K082816 
Product Classification System, X-Ray, Tomography, Computed - Product Code JAK
Product BrightSpeed Excel Select, BrightSpeed Edge Select ,BrightSpeed Elite Select and BrightSpeed Elite Computed Tomography X-ray systems with software version 09BW35.11 or 09HW30.4. The GE BrightSpeed Delight Series Computed Tomography X-ray system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes, for patients of all ages, including Axial, Cine, Helical, Cardiac, and Gated acquisitions. These images may be obtained either with or without contrast.
Code Information SERIAL 00000231382HM3 00000023378HM0 00000026180YC0 00000026454YC9 00000026731YC0 00000027157YC7 00000027449YC8 00000027452YC2 00000027453YC0 00000027686YC5 00000028252YC5 00000028254YC1 00000222727HM0 00000227688HM9 00000228343HM0 00000228344HM8 00000229115HM1 00000229117HM7 00000229777HM8 00000230875HM7 00000230876HM5 00000233120HM5 00000233775HM6 00000233776HM4 00000233777HM2 00000233778HM0 00000233779HM8 00000234401HM8 00000234402HM6 00000234403HM4 00000235055HM1 00000235351HM4 00000235353HM0 00000235356HM3 00000235357HM1 00000235790HM3 00000236520HM3 00000236521HM1 00000237191HM2 00000237192HM0 00000237945HM1 00000238307HM3 00000238310HM7 00000238691HM0 00000239959HM0 00000239960HM8 00000240263HM4 00000240264HM2 00000241406HM8 00000241410HM0 00000242443HM0 00000242897HM7 00000242900HM9 00000242901HM7 00000243389HM4 00000243392HM8 00000243918HM0 00000243987HM5 00000244184HM8 00000244186HM3 00000244187HM1 00000244444HM6 00000244900HM7 00000244901HM5 00000244902HM3 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00000241405HM0 00000248879HM9 00000248880HM7 00000249571HM1 00000250136HM9 00000258573HM5 00000230878HM1 00000248878HM1 00000241407HM6 00000250138HM5 00000250141HM9 00000251281HM2 00000253333HM9 00000253347HM9 00000256132HM2 00000256140HM5 00000227287HM0 00000246475HM8
Recalling Firm/
Manufacturer
GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha, Wisconsin 53188-1615
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
GE Healthcare has become aware of a potential set of circumstances that could cause X-ray continuation during an unexpected table stop on certain BrightSpeed systems (BrightSpeed Excel/Edge/Elite Select and BrightSpeed Elite Computed Tomography X-ray Systems ) if this event were to occur on your system, patient safety may be impacted.
FDA Determined
Cause 2
DESIGN: Software Design
Action The firm, GE Healthcare, sent an "URGENT MEDICAL DEVICE CORRECTION GE Ref: 22932" letter dated January 19, 2011 to its consignees/customers. The letter described the Safety Issue, Affected Product Details, Safety Instructions, Product Correction, Contact Information, and Additional Dosimetric Information. A second letter dated March 11, 2011 was sent to the consignee/customer letter consisting of a cover letter and an attachment. "This letter is to notify you of an error in the January 19, 2011, Urgent Medical Device Correction Letter, that you have already received (GE Ref: 22932). In the Safety Issue section of that letter it is written: "If this issue were to occur, it would result in the remainder of the exposure being delivered at the patient position where the table stopped up to the prescribed scan time or 30 seconds, whichever is shorter." The stated 30 seconds limitation is incorrect for your particular model. This information has been corrected on the attached Urgent Medical Device Correction letter, so please discard the original letter if it is still in your possession. " GE Healthcare will provide a software update for all affected systems to address the issue. A GE Healthcare service representative will contact you to arrange for this correction. The customers were also instructed as follows: prior to GE's installation of a software update, continue to monitor patient scanning closely. Should the table stop unexpectedly and X-ray remains on, manually stop the scan, and ensure that all potential users in your facility are made aware of this safety notification and the recommended actions. If you have any questions, please contact GE immediately at the following: United States: 800-437-1171; Japan: 0120-055-919; Korea: 1544-6119; Australia/New Zealand: 800-659-465 and China: 800-810-8188. For other countries please contact your local GE Healthcare Service Representative if you have any questions or concerns regarding this notifi.
Quantity in Commerce 479
Distribution Worldwide distribution: USA (nationwide) including states: AL, CA, CO, CT, FL, GA, ID, IL, IN, IA, KS, KY, LA, MI, MN, MS, MO, NE, NH, NJ, NM, NY, NC, OH, PR, RI, SC, SD, TN, TX, and WV; and countries including: URUGUAY, TURKEY, SWITZERLAND, SWEDEN, SPAIN, SOUTH AFRICA, SAUDI ARABIA, RUSSIAN FEDERATION, ROMANIA, REUNION, PUERTO RICO, PORTUGAL, POLAND, PARAGUAY, NEW ZEALAND, NETHERLANDS, MEXICO, MARTINIQUE, LEBANON, JAPAN, ITALY, INDONESIA, INDIA, HUNGARY, GREECE, GERMANY, FRANCE, EGYPT, COLOMBIA, CHINA, CHILE, BRAZIL, BELGIUM, BELARUS, BAHRAIN, AUSTRALIA, ANGOLA, ALGERIA. TUNISIA, THAILAND, SYRIAN ARAB REPUBLIC, PHILIPPINES, PARAGUAY, OMAN, NEW ZEALAND, MOROCCO, KUWAIT, KAZAKHSTAN, ISLAMIC REPUBLIC OF IRAN, ARGENTINA.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JAK and Original Applicant = GE MEDICAL SYSTEMS, LLC
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