Home / Recalls / Siemens Medical Solutions USA, Inc. / Z-1262-2016

Z-1262-2016 Class II Terminated

Recalled by Siemens Medical Solutions USA, Inc. — Hoffman Estates, IL

FDA device recall Z-1262-2016 was initiated by Siemens Medical Solutions USA, Inc. on Feb 26, 2016 and is designated Class II. 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… The recall status is terminated (terminated Dec 23, 2016). Affected quantity: 3090 units.

Recall Details

Product Type: Devices
Report Date: Apr 6, 2016
Initiation Date: Feb 26, 2016
Termination Date: Dec 23, 2016
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 3090 units

Product Description

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

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

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.

Code Information

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

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-1262-2016
openFDA file date: Oct 27, 2026
Loaded by RegDataLab: Oct 29, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.