Essenta DR - digital multifunctional x-ray system (application SW release 1.0.2 and lower). The device is intended for r
FDA device recall Z-1895-2008 · posted 2008-09-16 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems North America Co. Phillips
- Reason for recall
- Bright artifacts may appear on a patient image from a previous exposure, which might lead to a misdiagnosis.
- Action taken
- 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 you have questions.
- Root cause
- Software design
- Status
- Terminated
- Product code
- KPR
- Quantity affected
- 10 units
- Distribution
- Nationwide Distribution -- including states of SC, MN, CA, GA, TX, NY, OR and UT.
- Date initiated
- 2008-04-08
- Date posted
- 2008-09-16
- Date terminated
- 2011-06-07
- 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 |