Xoran MiniCAT X-ray imaging device

FDA device recall Z-1210-2015 · posted 2015-03-02 · Terminated

Recall details

Recalling firm

Xoran Technologies, LLC

Reason for recall

Out of tolerance kVp, Unexposed (black) frames, and Out of tolerance Dose.

Action taken

Xoran Planned Action : A Xoran Technologies service representative will re-measure and perform calibration to correct all affected systems for kVp and dose issues. For the image quality issue, the service representative will mark the black frame and then attempt to reconstruct an adequate image. CDRH also understands that you are continuing your investigation to determine the root cause and a more permanent corrective action for the 3 identified defects. 1. Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) district office coordinator noted below are to be included in the notification. 2. A customer notification letter which includes a statement that Xoran Technologies, LLC will without charge, remedy the defect or bring the product into compliance. 3. Xoran Technologies, LLC will continue to evaluate why the kVp is not always within Xoran specifications, why the unexposed frames continues to occur, and why the dose is not always within Xoran specifications and identify the actions needed to resolve these issues by July 1, 2015. Xoran will communicate the results of this evaluation and any necessary actions to both customers and CDRH. Further questions please call (734) 663-7194.

Root cause

Radiation Control for Health and Safety Act

Status

Terminated

Product code

JAK

Quantity affected

432

Distribution

Nationwide Distribution

Date initiated

2014-09-08

Date posted

2015-03-02

Date terminated

2016-02-02

Location

Ann Arbor, MI

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