GE LightSpeed VCT Scanner System, models 5212920-300… recallZ-0368-2011 · GE Healthcare, LLC · initiated Sep 3, 2010

Why it was recalled

GE has become aware of a potential set of circumstances that could cause x-ray continuation during an unexpected table stop on certain LightSpeed VCT and BrightSpeed systems.

FDA root cause category: Software design

What the company is doing

An Urgent Medical Device Correction letter dated September 2, 2010 was sent to consignees beginning September 3, 2010. This letter addressed the LightSpeed VCT systems. Another Urgent Medical Device Correction letter, dated September 24, 2010 was sent September 24, 2010 for the BrightSpeed Systems. The letters described the issue and provided safety instructions for the health care provider to be aware if the table should stop unexpectedly and the x-ray remains on to manually stop the scan until the devices software is upgraded. If you have any questions, please contact the US (800) 437-1171, Japan 0120-055-919, Korea 1544-6119, Australia/New Zealand 800 659 465, China 800-810-8188; for other countries, please contact your local GE Healthcare Services Representative.

Recall details

Recall number

Z-0368-2011

Recall class

Not yet classified by the FDA

Status

Terminated

Initiated by the company

Sep 3, 2010

Posted by the FDA

Nov 15, 2010

Recalling firm

GE Healthcare, LLC

Quantity

68

Product code

JAK

FDA submissions

K052855, K082761, K082816

Distribution

Worldwide distribution: USA including states of: MI, NM, OH, TX, and Puerto Rico and countries including: Algeria, Argentina, Australia, Austria, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Germany, Greece, Guatemala, Honduras, Hungary, India, Indonesia, Ireland, Islamic Republic of Iran, Israel, Italy, Jamaica, Japan, Kenya, Lebanon, Malaysia, Mauritania, Mexico, Morocco, Netherlands, New Caledonia, New Zealand, Nigeria, Norway, Pakistan, Paraguay, Philippines, Poland, Portugal, Republic of Korea, Romania, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Togo, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela, and Viet Nam.

Product description

GE LightSpeed VCT Scanner System, models 5212920-300, 5212920-310, 5311595-10. Composed of a gantry, patient table, operator console, computer, and PDU and includes image acquisition hardware, image acquisition and reconstruction software, associated accessories and connections/interfaces to accessories. GE Healthcare, 3000 North Grandview, Waukesha, WI 53188 USA. Is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes, including Axial, Cine, Helical (Volumetric), Cardiac, and Gated acquisitions.

Other devices under the same FDA submission

3 devices cleared under K052855, K082761, K082816 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

• Operator Console for BrightSpeed Elite and BrightSpeed Elite Select

  GE Hangwei Medical Systems Company Ltd. · System, X-Ray, Tomography, Computed
  1 recall0 reports
• Optima CT540

  GE Hangwei Medical Systems Company Ltd. · System, x-ray, tomography, computed
  1 recall0 reports
• Optima CT540 N

  GE Hangwei Medical Systems Company Ltd. · System, x-ray, tomography, computed
  1 recall0 reports

Other products in the same recall event

The FDA groups related products into one recall event (event 56814).

• Z-0369-2011 · Terminated
  GE BrightSpeed Excel/Edge/Elite Select / Elite CT Scanner System, models 2377708-560, 5377708-540, 5377708-560. Composed of a gantry, patient table, operator console, computer, an…