Recall Z-1559-2013— Hitachi Medical Systems America Inc
Class II · Terminated
Class II FDA medical device recall by Hitachi Medical Systems America Inc, initiated 2013-01-31, terminated 2013-09-20. It names 3 FDA 510(k) clearances: K113145, K072279, K052172. 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..
- Recalling firm
- Hitachi Medical Systems America Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-01-31
- Terminated
- 2013-09-20
- Firm location
- Twinsburg, OH, United States
510(k) clearances named in this recall
3 on FDA's record- K113145 — ECHELON OVAL MRI SYSTEM
- K072279 — MAGNETIC RESONANCE DIAGNOSTIC DEVICE
- K052172 — HHF1 MAGNETIC RESONANCE IMAGING SYSTEM
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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 for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.