Mobile Diagnostic X-Ray System with Digital Panel
This recall has been terminated (originally issued November 28, 2012).
- Company
- Philips Healthcare Inc.
- Recall Initiated
- November 28, 2012
- Terminated
- May 31, 2018
- Recall Number
- Z-1706-2017
- Quantity
- 220 systems
- Firm Location
- Andover, MA
- Official Source
- View on FDA website ↗
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.
Distribution
Nationwide (AR, AZ, CA, DE, FL, GA, IA, IL, IN, KS, MD, MI, MN, NC, NM, NY, OH, OR, PA, SC, TX, VT, WI)
Lot / Code Info
*** All units ***
Root Cause
Software design
Action Taken
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.