—#117359

Product

Mobile Diagnostic X-Ray System with Digital Panel

FDA product code: IZL — System, X-Ray, Mobile
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K111725
Affected lot / code info: *** All units ***

Why it was recalled

When the operator moves an image to another view then the electronic marker might be placed at the wrong anatomical position in the resulting image.

Root cause (FDA determination)

Software design

Action the firm took

Philips Medicals Systems distributed an "URGENT Field Safety Notice" alerting customers of the defect on November 28, 2012. Customers are requested to manually rotate images by using the rotation tool.Customers are also recommended to check whether the automatic marker is set correctly, especially after a manual image rotation is performed. The marker can be corrected manually with the annotation tool.

Recalling firm

Firm: Philips Healthcare Inc.
Address: 3000 Minuteman Road, Andover, Massachusetts 01810

Distribution

Distribution pattern: Nationwide (AR, AZ, CA, DE, FL, GA, IA, IL, IN, KS, MD, MI, MN, NC, NM, NY, OH, OR, PA, SC, TX, VT, WI)

Timeline

Recall initiated: 2012-11-28
Terminated: 2018-05-31
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #117359. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.