Z-1696-2016Class II

Philips Healthcare DuraDiagnost stationary X-ray system

Name: Z-1696-2016 Philips Healthcare DuraDiagnost stationary X-ray system
Creator: Philips Healthcare
Published: 2015-11-10
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2015-11-10 / Terminated

FDA source

Philips Healthcare began a recall of Philips Healthcare DuraDiagnost stationary X-ray system on 2015-11-10. FDA classified it as Class II and gives the reason as "The detector may signal that it is ready for acquisition when it actually is not, resulting in failure to properly acquire the X-ray image". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1696-2016
Classification: Class II
Status: Terminated
Initiated: 2015-11-10
Posted: 2016-06-03
Terminated: 2017-05-03
Recalling firm: Philips North America LLC
Product: Philips Healthcare DuraDiagnost stationary X-ray system
Product code: KPR System, X-Ray, Stationary
Reason for recall: The detector may signal that it is ready for acquisition when it actually is not, resulting in failure to properly acquire the X-ray image.
FDA root cause: Radiation Control for Health and Safety Act
Action: Philips Healthcare plans to correct the defect at no cost to customers by implementing a field correction involving the installation of new software. 1. You will contact customers and initiate a software update to correct the defect. 2. You will install the software and perform testing to ensure the software update was effective. 3. The customer notification letter which includes a statement that you will without charge, remedy the defect or bring the product into compliance. For further questions, please call 1-800- 722-9377.
Quantity in commerce: 5
Distribution: USA (nationwide) Distribution to the states of : ( DuraDiagnost) to the states of : OH, CA, WA and NE. (DigitalDiagnost) to the states of : AK, AZ, AL, CA, CT, CO, DE, FL, GA, HI, ID, KY, LA, MA, MN, MD, MS, ME, MO, NE, NY, ND, OH and PA.
Product codes and lots: software version - 4.0.2, 4.0.3, 4.0.4 into 4.0.5

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1696-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1695-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-15	2016-06-03
Z-1696-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-15	2016-06-03

Product code KPR

K141381Class IIDuradiagnostPhilips Healthcare (Suzhou) Co., Ltd. / cleared 2014-06-12

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)