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U.S. Department of Health and Human Services

Class 2 Device Recall Essenta DR Xray system

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 Class 2 Recall
Essenta DR Xray system
see related information
Date Posted October 06, 2010
Recall Status1 Terminated on October 07, 2010
Recall Number Z-0012-2011
Recall Event ID 49138
Premarket Notification
510(K) Number
K070528 
Product Classification System, X-Ray, Stationary - Product Code KPR
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.
Code Information 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.
Recalling Firm/
Manufacturer
Philips Medical Systems North America Co. Phillips
22100 Bothell Everett Hwy
Bothell, Washington 98021-8431
For Additional Information Contact Customer Care Service Center
425-487-7602
Manufacturer 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.
FDA Determined
Cause 2
OTHER/UNDETERMINED: Pending
Action 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.
Quantity in Commerce 23 units
Distribution Nationwide distribution: CA, GA, FL, KS, MN, NY, OH, OR, SC, TN, TX, UT, and WA.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = KPR and Original Applicant = PHILIPS MEDICAL SYSTEMS GMBH, DMC
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