Terminated

The E.CAM gamma camera system Product Usage: The E.CAM gamma camera system is a SPECT system and measures the distribution of radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body

FDA Recall Z-1262-2016 · Posted None

Recalling FirmSiemens Medical Solutions USA, Inc.

Recall StatusTerminated

Product CodeKPS

Date Initiated2016-02-26

Date Terminated2016-12-23

Product Quantity3090 units

Reason for Recall

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

Firm Action

Siemens sent a Customer Advisory Notice CAN 001 -2016 to all affected customers describing the recall and additional actions to take. Siemens updated user instructions, drafting customer advisory letter, and obtaining internal and external approvals, and translation of this content. Customer Advisory Notice Letter provided to each impacted consignee will document receipt of the letter and additional attempts will be made until such receipt is acknowledged. Instructions provided in letter explain that Hospital staff should inform end users of the enhancements that have been made to the user manual and continue to use your system. It also instruct end user that the advisory notice and addendum instructions should be placed with the system's instructions for use. The system use information should be available to all operators of the system. Siemens advises that if the end user has sold their equipment and it is no longer in their possession, They kindly ask that the end user forward the notice to the new owner of this equipment. They should inform Siemens about the new owner of the equipment. Adverse events or quality problems experienced with the use of this product should be reported to Siemens through the contact information provided below and may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax. If the end user has any questions regarding the important notice, they should contact their local Service representative at the contact numbers provided below. -America: 1-800-888-7436 -Europe, Middle East, and Africa: +49 9131 940 4000 -Asia and Australia: +86 (21) 3811 2121

Root Cause

Labeling design

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.