Essenta DR is a digital multifunctional X-ray systems, suitable for all routine radiographic exams, including specialist
FDA device recall Z-0012-2011 · posted 2010-10-06 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems North America Co. Phillips
- Reason for recall
- 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.
- Action taken
- 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 Software. All affected units will receive a software upgrade to correct the issue. Customers should contact Philips Customer Care Service at 800-772-9377, #5, #4, #1 and reference FCO 712000031 for any questions or support concerning the recall.
- Root cause
- Other
- Status
- Terminated
- Product code
- KPR
- Quantity affected
- 23 units
- Distribution
- Nationwide distribution: CA, GA, FL, KS, MN, NY, OH, OR, SC, TN, TX, UT, and WA.
- Date initiated
- 2008-08-15
- Date posted
- 2010-10-06
- Date terminated
- 2010-10-07
- Location
- Bothell, WA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PHILIPS ESSENTA DR (K070528) | Philips Medical Systems GmbH, Dmc | 2007-03-09 |