FDAFDA · Food and drugs·Recall number Z-1263-2016
The Symbia gamma camera system Product Usage: The Symbia gamma camera system is a computed tomography x-ray system which is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
Published April 6, 2016 · Recall initiated: February 26, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
We received a customer complaint that Siemens reported via the MedWatch process (1423253-2015-00002). The result of a Hazard Analysis and CAPA investigation, we have determined that for e.cam or Symbia E systems that although the existing user manual is correct, additional supplemental instructions, with the inclusion of visual aids, may further clarify and emphasize the proper collimator change
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Siemens Medical Solutions USA, Inc.
- Distributor
- Worldwide Distribution - US Nationwide in the states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and Puerto Rico.***** Foreign Consignees: Albania, Algeria, Angola, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Botswana, Brazil, Bulgaria, Canada, Chile, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Rep., Ecuador, Egypt, El Salvador, Finland, France, Georgia, Germany, Ghana, Greece, Hong Kong, India, Indonesia, Iran, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kosovo, Kuwait, Libya, Malaysia, Mauritius, Mexico, Morocco, Myanmar, Netherlands, New Zealand, Nigeria, Norway, Oman, P.R. China, Pakistan, Palestinian Ter, Peru, Philippines, Poland, Portugal, Qatar, Rep. of Yemen, Republic Korea, Romania, Russian Fed., Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad,Tobago, Tunisia, Turkey, U.A.E., Ukraine, United Kingdom, Uruguay and Vietnam.
- Lot
- 10275879, 10413009, 04380213, 04380221, 05242826, 05977066, 05977074, 05984005, 05989079, 05989087, 05989095, 05991109, 05991117, 05992099, 07324119, 07324135, 07324143, 07324150, 07760809, 07760932, 07761161, 07823920, 07823938, 07823946, 07823953, 07823961, 07823979, 10151531, 10151532, 10520745
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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