—#93207

Product

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 built in flat panel detector and in addition for free exposures on radiographic cassettes.

FDA product code: KPR — System, X-Ray, Stationary
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K070528
Affected lot / code info: Devices were identified as SITE numbers: 553491, 554498, 554944, 553270, 554358, 556089, 556275, 555457, 556080, 557203, 41446107, 41446304, 41443692, 41446097, 41445359, 41445529, 41585399, 41586528, 41796147, 41958550, 42252302, 42616819, and 42865052.

Why it was recalled

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 (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Philips Medical Systems North America Co. Phillips
Address: 22100 Bothell Everett Hwy, Bothell, Washington 98021-8431

Distribution

Distribution pattern: Nationwide distribution: CA, GA, FL, KS, MN, NY, OH, OR, SC, TN, TX, UT, and WA.

Timeline

Recall initiated: 2008-08-15
Posted by FDA: 2010-10-06
Terminated: 2010-10-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #93207. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.