Z-1262-2016Class II

The E.CAM gamma camera system

Name: Z-1262-2016 The E.CAM gamma camera system
Creator: Siemens Medical Solutions USA, Inc.
Published: 2016-02-26
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2016-02-26 / Terminated / root cause: labeling and UDI

FDA source

Siemens Medical Solutions USA, Inc. began a recall of 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... on 2016-02-26. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1262-2016
Classification: Class II
Status: Terminated
Initiated: 2016-02-26
Posted: 2016-03-25
Terminated: 2016-12-23
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: 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
Product code: KPS System, Tomography, Computed, Emission
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
Root cause tag: labeling and UDI
FDA 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 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
Quantity in commerce: 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 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1262-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1262-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-06	2016-03-25
Z-1263-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-06	2016-03-25

Product code KPS

K142006Class IISymbia 6.0Siemens Medical Solutions USA, Inc. / cleared 2014-08-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)