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Terminated

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 Recall Z-1895-2008 · Posted 2008-09-16

Recall StatusTerminated
Product CodeKPR
Date Initiated2008-04-08
Date Terminated2011-06-07
Product Quantity10 units

Reason for Recall

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

Firm Action

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

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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