RecallRadar

FDA Device recall Z-0687-2016

The e.cam Dual Signature Gamma Camera system

On 2016-01-27 the FDA classified a Class II recall of The e.cam Dual Signature Gamma Camera system by Siemens Medical Solutions Usa, citing 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 cu….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0687-2016
ClassificationClass II
Statusterminated
Initiated2015-12-31
Published2016-01-27
Last updated2026-09-13 11:54 UTC
CompanySiemens Medical Solutions Usa
DistributionFL, GA, IN, MD, MO, NY, SD, TN

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.

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.

Identifiers

code_info
e.cam systems that were refurbished from 04/06/15 to 10/06/15. Material number 10151531, serial number 70004; Material…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.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0687-2016%22

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