FDA Device recall Z-1559-2013
Echelon, Echelon Oval and Oasis MR imaging device systems
- FDA Device
- Class II
- terminated
- Published 2013-06-26
On 2013-06-26 the FDA classified a Class II recall of Echelon, Echelon Oval and Oasis MR imaging device systems by Hitachi Medical Systems America, citing hitachi discovered a software error that can occur when simultaneously scanning a patient while processing images previously acquired from a different patient. The software error….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1559-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-01-31 |
| Published | 2013-06-26 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Hitachi Medical Systems America |
| Distribution | US |
Product
Echelon, Echelon Oval and Oasis MR imaging device systems; one unit per box. The Echelon, Echelon Oval and Oasis MR systems are imaging devices, and are intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation. The MR systems produce transverse, coronal, sagittal, oblique, and curved cross-sectional images that display the internal structure of the head, body, or extremities.
Reason
Hitachi discovered a software error that can occur when simultaneously scanning a patient while processing images previously acquired from a different patient. The software error can occur randomly. The error causes an image in the processed dataset to have the same unique identifier (UID) as in the scanning dataset. The processed image is stored in the place of the original image, which is lost.
Identifiers
| code_info | The following serial numbers are associated with this recall: Echelon - V061, V062, and V065 Oasis - M009, M017, M067…The following serial numbers are associated with this recall: Echelon - V061, V062, and V065 Oasis - M009, M017, M067, M071, M084, M106-M108, M110-M141 inclusive, and M952 Echelon Oval - Y001-Y005 inclusive |
|---|
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-1559-2013%22
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