BrightSpeed Excel Select…

Date posted by the FDA

May 19, 2011

Status

Terminated

Filed by

GE Healthcare, LLC

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.

Reason

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.

Distribution pattern

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.

Quantity

479

Codes and lots

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 00000244903HM1 00000244905HM6 00000244912HM2 00000246077HM2 00000247806HM3 00000247808HM9 00000248444HM2 00000248881HM5 00000248885HM6 00000249564HM6 00000249565HM3 00000249567HM9 00000249568HM7 00000249569HM5 00000249572HM9 00000249573HM7 00000249574HM5 00000249575HM2 00000249576HM0 00000249577HM8 00000250128HM6 00000250130HM2 00000250132HM8 00000250133HM6 00000250135HM1 00000250139HM3 00000250143HM5 00000251029HM5 00000251282HM0 00000251283HM8 00000251284HM6 00000251397HM6 00000252095HM5 00000252096HM3 00000252097HM1 00000253328HM9 00000253330HM5 00000253331HM3 00000253337HM0 00000253338HM8 00000253346HM1 00000255464HM0 00000256201HM5 00000256623HM0 00000257360HM8 00000257361HM6 00000257363HM2 00000257364HM0 00000257369HM9 00000257373HM1 00000258371HM4 00000258574HM3 00000259698HM9 00000259938HM9 00000259943HM9 00000260494HM0 00000245520HM2 00000237827HM1 00000252063HM3 00000247809HM7 00000248355HM0 00000248526HM6 00000248527HM4 00000249931HM7 00000246524HM3 00000232142HM0 00000238305HM7 00000231383HM1 00000232143HM8 00000234400HM0 00000239137HM3 00000239453HM4 00000248886HM4 00000250131HM0 00000252917HM0 00000255484HM8 00000258576HM8 00000227690HM5 00000256130HM6 00000226709HM4 00000228702HM7 00000228703HM5 00000229114HM4 00000229116HM9 00000229118HM5 00000229776HM0 00000229778HM6 00000231384HM9 00000236278HM8 00000241411HM8 00000241412HM6 00000242896HM9 00000245521HM0 00000245525HM1 00000247969HM9 00000248445HM9 00000248446HM7 00000248447HM5 00000248448HM3 00000248883HM1 00000248884HM9 00000249562HM0 00000250140HM1 00000251399HM2 00000252062HM5 00000252064HM1 00000252916HM2 00000253341HM2 00000253344HM6 00000253348HM7 00000255349HM3 00000255350HM1 00000256200HM7 00000256622HM2 00000258533HM9 00000240938HM1 00000253342HM0 00000026178YC4 00000229779HM4 00000229780HM2 00000235358HM9 00000239454HM2 00000246523HM5 00000248524HM1 00000248529HM0 00000252065HM8 00000252339HM7 00000252343HM9 00000252977HM4 00000255348HM5 00000256625HM5 00000256851HM7 00000257618HM9 00000257622HM1…

Recall started

Jan. 19, 2011

Device type

System, X-Ray, Tomography, Computed

Root cause (FDA)

Software design

What the company told customers

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

Recall number

Z-2214-2011

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-2214-2011. The agency record governs; check it and the company before acting.