Recall Z-1262-2016 ยท KPS System, Tomography, Computed, Emission
Siemens Medical Solutions USA, Inc.
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
| Date | Feb 26, 2016 |
| Status | Terminated |
| Reason | 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 |
| Root cause | Labeling design |
| 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 |
| Quantity | 3090 units |
| Distribution | 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 Consignee |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K142006 | SYMBIA 6.0 Siemens Medical Solutions USA, Inc., Aug 21, 2014 |