Z-0687-2016 Class II Terminated
FDA device recall Z-0687-2016 was initiated by Siemens Medical Solutions USA, Inc. on Dec 31, 2015 and is designated Class II. 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. The recall status is terminated (terminated Dec 23, 2016). Affected quantity: 10.
Recall Details
- Product Type
- Devices
- Report Date
- Jan 27, 2016
- Initiation Date
- Dec 31, 2015
- Termination Date
- Dec 23, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10
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.
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.
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.
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.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0687-2016
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026