Z-1895-2008

Essenta DR - digital multifunctional x-ray system (application SW release 1.0.2 and lower). The device is...

Name: Z-1895-2008 Essenta DR - digital multifunctional x-ray system (application SW release 1.0.2 and lower). The device is...
Creator: Philips Medical Systems North America Co. Phillips
Published: 2008-04-08
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2008-04-08 / Terminated / root cause: software

FDA source

Philips Medical Systems North America Co. Phillips began a recall of Essenta DR - digital multifunctional x-ray system (application SW release 1.0.2 and lower). The device is intended for routine exams, including specialist... on 2008-04-08. The reason FDA records is "Bright artifacts may appear on a patient image from a previous exposure, which might lead to a misdiagnosis". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1895-2008
Status: Terminated
Initiated: 2008-04-08
Posted: 2008-09-16
Terminated: 2011-06-07
Recalling firm: Philips North America LLC
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.
Product code: KPR System, X-Ray, Stationary
Reason for recall: Bright artifacts may appear on a patient image from a previous exposure, which might lead to a misdiagnosis.
Root cause tag: software
FDA root cause: Software design
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.
Quantity in commerce: 10 units
Distribution: Nationwide Distribution -- including states of SC, MN, CA, GA, TX, NY, OR and UT.
Product codes and lots: 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.

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)