Medical Device Recall: Z-0012-2011

FDA Recalls dataset · Firm: Philips Medical Systems North America Co. Phillips · Status: Terminated

Recall Action Class: N/A Date Initiated: 2008-08-15 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0012-2011.

Recall Res Number
Z-0012-2011
FEI Number
1000524572
Recall Status
Terminated
Recall Classification
N/A
Date Initiated
2008-08-15
Date Posted
2010-10-06
Date Terminated
2010-10-07
Product Code
KPR
Event Number
49138
Product Quantity
23 units
Product Description 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.
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.
Action Details 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.
Distribution Pattern Nationwide distribution: CA, GA, FL, KS, MN, NY, OH, OR, SC, TN, TX, UT, and WA.
Code Information / Serial Numbers 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.

Related Establishments / Registrations

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