Z-0012-2011

Essenta DR is a digital multifunctional X-ray systems, suitable for all routine radiographic exams, including...

Name: Z-0012-2011 Essenta DR is a digital multifunctional X-ray systems, suitable for all routine radiographic exams, including...
Creator: Philips Medical Systems North America Co. Phillips
Published: 2008-08-15
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2008-08-15 / Terminated

FDA source

Philips Medical Systems North America Co. Phillips began a recall of Essenta DR is a digital multifunctional X-ray systems, suitable for all routine radiographic exams, including specialist areas like trauma or pediatric work... on 2008-08-15. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0012-2011
Status: Terminated
Initiated: 2008-08-15
Posted: 2010-10-06
Terminated: 2010-10-07
Recalling firm: Philips North America LLC
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.
Product code: KPR System, X-Ray, Stationary
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 root cause: Other
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.
Product codes and lots: 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.

Product code KPR

K070528Class IIPhilips Essenta DrPhilips Medical Systems GmbH, Dmc / cleared 2007-03-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)