Mobile Diagnostic X-Ray System with Digital Panel
FDA Recall Z-1706-2017 · Posted None
Recalling FirmPhilips Healthcare Inc.
Recall StatusTerminated
Product CodeIZL
Date Initiated2012-11-28
Date Terminated2018-05-31
Product Quantity220 systems
Reason for Recall
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.
Firm Action
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.
Root Cause
Software design
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)
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.