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