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U.S. Department of Health and Human Services

Class 2 Device Recall e.cam Dual Signature; Gamma Camera

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  Class 2 Device Recall e.cam Dual Signature; Gamma Camera see related information
Date Initiated by Firm December 31, 2015
Date Posted January 21, 2016
Recall Status1 Terminated 3 on December 23, 2016
Recall Number Z-0687-2016
Recall Event ID 73038
510(K)Number K142006  
Product Classification System, gamma camera, tomography, computed - Product Code JAK
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.
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.
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc.
2501 Barrington Rd
Hoffman Estates IL 60192-2061
For Additional Information Contact Laura M. Meyer
847-304-6022
Manufacturer 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.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JAK and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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