Recall Z-1706-2017 ยท IZL System, X-Ray, Mobile
Philips Healthcare Inc.
Mobile Diagnostic X-Ray System with Digital Panel
| Date | Nov 28, 2012 |
| Status | Terminated |
| Reason | 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 | Software design |
| 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. |
| Quantity | 220 systems |
| 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) |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K111725 | MOBILEDIAGNOST WDR Sedecal., Sa., Jul 19, 2011 |