Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Samsung GU60A system- Digital X-ray Imaging Systems are intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications

FDA Recall Z-3036-2017 · Posted None

Recalling FirmNeuroLogica Corporation
Recall StatusTerminated
Product CodeKPR
Date Initiated2017-05-24
Date Terminated2018-07-09
Product Quantity87 units

Reason for Recall

When performing the Stitching function on GU60A system, unintended area is exposed to radiation

Firm Action

Neurologica will bring defect into compliance : 1.All facilities were notified via a customer notification letter. 2.Samsung will release improved software to avoid unintended exposure. When setting the stitching area, if there is an over exposed area, the height of the swivel arm will be lowered over the exposed area and the first region (first image) will be collimated by the bottom blade. 3.A software patch was developed: SW3.01 was released on 05/08/2017 and SW1.00 was released on 07/28/17. 4.The software patch will be installed on the affected devices. 5.Samsung has provided the statement and assurance that all corrections will be performed free of charge. 6.All units will be provided with updated software by November 11, 2017. For further questions, please call (978) 564-8500.

Root Cause

Device Design

Distribution Pattern

Nationwide Distribution

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑