Skip to content
Recall Observatory FDA recall evidence

Device product

The e.cam Dual Signature Gamma Camera system. Used to detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588keV.

Z-0687-2016

December 31, 2015

Class II

Product summary

Firm
Siemens Medical Solutions USA, Inc.
Event
Event 73038
Status
Terminated
Classification
Class II
Quantity
10
Official record key
device-enforcement:Z-0687-2016

Official wording

Reason: To provide operator instruction manuals for the e.cam Dual Signature; Gamma Camera that were not sent in its entirety when the e.cam systems were refurbished and shipped to the customer.

Code information: e.cam systems that were refurbished from 04/06/15 to 10/06/15. Material number 10151531, serial number 70004; Material number 10151532 serial numbers 70038, 70040, 70041, 70042, 70043, 70044, 70039, 70045, and 70046.

Distribution pattern: Distributed in the states of Florida, New York, Indiana, Maryland, South Dakota, Missouri, Tennessee, and Georgia, and the countries of Australia and India.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    To provide operator instruction manuals for the e.cam Dual Signature; Gamma Camera that were not sent in its entirety when the e.cam systems were refurbished and shipped to the customer.