Echelon, Echelon Oval and Oasis MR imaging device systems; one unit per box. The Echelon, Echelon Oval and Oasis MR syst

FDA device recall Z-1559-2013 · posted 2013-06-19 · Terminated

Recall details

Recalling firm

Hitachi Medical Systems America Inc

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.

Action taken

Hitachi sent a Device Correction Notice beginning on January 31,2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Software correction is targeted to start by March 1, 2013. All sites will be visited by Hitachi Service to perform corrections. All letters are recorded by tracking number and date received by the customers. For further questions please call 800-800-3106 x 3720.

Root cause

Software design

Status

Terminated

Product code

LNH

Quantity affected

45 system units

Distribution

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.

Date initiated

2013-01-31

Date posted

2013-06-19

Date terminated

2013-09-20

Location

Twinsburg, OH

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