Recall Z-1895-2008 ยท KPR System, X-Ray, Stationary
Philips Medical Systems North America Co. Phillips
Essenta DR - digital multifunctional x-ray system (application SW release 1.0.2 and lower). The device is intended for routine exams, including specialist areas like trauma or pediatric work, excluding mammography.
| Date | Sep 16, 2008 (initiated Apr 8, 2008) |
| Status | Terminated |
| Reason | Bright artifacts may appear on a patient image from a previous exposure, which might lead to a misdiagnosis. |
| Root cause | Software design |
| Action | On 4/08/08, the firm notified customers by letter, sent by certified mail. The letter explained the recall and advised customers of the following: "If direct radiation reaches the detector, the collimation should be not too tight, such that the area of direct radiation is larger than 30 mm x 30 mm. (1.2 inch by 1.2 inch). The reason is that a minimum area is needed to detect and prevent memory artifact... All possibly affected products in the field will be upgraded with FCO 71200026 to resolve the issue." Contact Sarah Baxter at 425-487-7665 or Philips Call Center at 800-722-9377, #5, #2 if |
| Quantity | 10 units |
| Distribution | Nationwide Distribution -- including states of SC, MN, CA, GA, TX, NY, OR and UT. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K070528 | PHILIPS ESSENTA DR Philips Medical Systems GmbH, Dmc, Mar 9, 2007 |