The e.cam Dual Signature Gamma Camera system. Used to detect or image the distribution of radionuclides in the body or o
FDA device recall Z-0687-2016 · posted 2016-01-21 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc.
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- JAK
- Quantity affected
- 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.
- Date initiated
- 2015-12-31
- Date posted
- 2016-01-21
- Date terminated
- 2016-12-23
- Location
- Hoffman Estates, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SYMBIA 6.0 (K142006) | Siemens Medical Solutions USA, Inc. | 2014-08-21 |