Z-0687-2016Class II

The e.cam Dual Signature Gamma Camera system. Used to detect or image the distribution of radionuclides in...

Name: Z-0687-2016 The e.cam Dual Signature Gamma Camera system. Used to detect or image the distribution of radionuclides in...
Creator: Siemens Medical Solutions USA, Inc.
Published: 2015-12-31
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2015-12-31 / Terminated / root cause: packaging

FDA source

Siemens Medical Solutions USA, Inc. began a recall of 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... on 2015-12-31. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0687-2016
Classification: Class II
Status: Terminated
Initiated: 2015-12-31
Posted: 2016-01-21
Terminated: 2016-12-23
Recalling firm: Siemens Medical Solutions USA, Inc.
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.
Product code: JAK System, X-Ray, Tomography, Computed
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.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: An updated Customer Advisory Notice Letter will be provided to each impacted consignee. The receipt of the letter will be documented and additional attempts will be made until such receipt is acknowledged. The Customer Advisory Notice asks that the letter be placed with systems instructions for use along with all provided user documentation. It also advises the consignee to forward the notice to the new customer if the equipment was sold. Customers with questions regarding the Customer Advisory Notice can contact their local Service representative or use the following contact number 1-800-888-7436.
Quantity in commerce: 10
Distribution: Distributed in the states of Florida, New York, Indiana, Maryland, South Dakota, Missouri, Tennessee, and Georgia, and the countries of Australia and India.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0687-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0687-2016	Class II	Terminated	Voluntary: Firm initiated	2016-01-27	2016-01-21

Product code JAK

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)