Z-1559-2013 Class II Terminated
FDA device recall Z-1559-2013 was initiated by Hitachi Medical Systems America Inc on January 31, 2013 and is designated Class II. 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. T… The recall status is terminated (terminated September 20, 2013). Affected quantity: 45 system units.
Recall Details
- Product Type
- Devices
- Report Date
- June 26, 2013
- Initiation Date
- January 31, 2013
- Termination Date
- September 20, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 45 system units
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.
Distribution Pattern
Worldwide Distribution - US Nationwide including the states of AZ, CA, CO, DE, FL, IL, IN, KS, KY, MD, NC, ND, NY, OH, OR, PA, TX, VA, WA, and WI. One (1) system unit was also distributed to Mexico.
Code Information
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