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Terminated

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.

FDA Recall Z-0687-2016 · Posted 2016-01-21

Recalling FirmSiemens Medical Solutions USA, Inc.
Recall StatusTerminated
Product CodeJAK
Date Initiated2015-12-31
Date Terminated2016-12-23
Product Quantity10

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.

Firm 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.

Root Cause

Packaging process control

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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