—#69721

Product

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.

FDA product code: KPR — System, X-Ray, Stationary
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K070528
Affected lot / code info: Serial Number: 368645, 372631, 375371/SN0800002, 375730/SN07000032, 375372/SN07000028, 383083/SN07000023, 378493/SN07000025, 379442/SN0800001, 379183/SN07000030 and 379050/SN0800005; Equip No: 553491, 554498, 554944, 554358, 553270, 557203, 556089, 556080, 555457 and 556275.

Why it was recalled

Bright artifacts may appear on a patient image from a previous exposure, which might lead to a misdiagnosis.

Root cause (FDA determination)

Software design

Action the firm took

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.

Recalling firm

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

Distribution

Distribution pattern: Nationwide Distribution -- including states of SC, MN, CA, GA, TX, NY, OR and UT.

Timeline

Recall initiated: 2008-04-08
Posted by FDA: 2008-09-16
Terminated: 2011-06-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #69721. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.