FDA Device recall Z-1519-2013
GE Healthcare Senographe Essential System
- FDA Device
- Class II
- terminated
- Published 2013-07-03
On 2013-07-03 the FDA classified a Class II recall of GE Healthcare Senographe Essential System by Ge Healthcare, citing GE Healthcare has recently become aware of a potential issue due to inaccessible Operator Instructions associated with the defective Operator Manual CD of the Senographe Essential.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1519-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-01-14 |
| Published | 2013-07-03 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ge Healthcare |
| Distribution | US |
Product
GE Healthcare Senographe Essential System. The Senographe 2000D system generates digital mamnmographic images that can be used for screening and in the diagnosis of breast cancer. The Senographe 2000D is intended to be used in the same clinical applications as traditional film-based mamnmographic systems.
Reason
GE Healthcare has recently become aware of a potential issue due to inaccessible Operator Instructions associated with the defective Operator Manual CD of the Senographe Essential.
Identifiers
| code_info | Models 5144816-10 rev 2, 3 or 6 and 5144816-10-LE rev1. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1519-2013%22
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