Recall Z-0012-2011 ยท KPR System, X-Ray, Stationary
Philips Medical Systems North America Co. Phillips
Essenta DR is a digital multifunctional X-ray systems, suitable for all routine radiographic exams, including specialist areas like trauma or pediatric work, excluding mammography. It is designed for radiographic examination of the standing or seated patient or the recumbent patient in combination with a mobile X-ray table (trolley). The intended use is from direct digital imaging using the buil
| Date | Oct 6, 2010 (initiated Aug 15, 2008) |
| Status | Terminated |
| Reason | When a patient is selected in the patient list and examination tab pressed with background query running at the same time, the wrong patient may be selected. |
| Root cause | Other |
| Action | Philip Medical System sent an "URGENT-Device Correction" letter dated August 13, 2008 to their customers. The letter describes the recalled product as Essenta DR Patient and Image Data Software (SW) release 1.0. The firm informs the customers that when patient is selected in patient list and examination tab pressed with background query running at the same time, there is a risk that the wrong patient is selected on the Essenta DR Computed Radiography System. Customers are advised to verify the selected patient's information before releasing an exposure while the firm works on upgrading the |
| Quantity | 23 units |
| Distribution | Nationwide distribution: CA, GA, FL, KS, MN, NY, OH, OR, SC, TN, TX, UT, and WA. |
| 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 |