Siemens Medical Solutions USA, Inc.: Medical Device Recall in 2016 - (Recall #: Z-0687-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.
Product Description:

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.

Product Classification:

Class II

Date Initiated: December 31, 2015
Date Posted: January 27, 2016
Recall Number: Z-0687-2016
Event ID: 73038
Reason for Recall:

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.

Status: Terminated
Product Quantity: 10
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.

Voluntary or Mandated:

Voluntary: Firm initiated