Z-2682-2016Class II

Philips DuraDiagnost stationary X-ray system

Name: Z-2682-2016 Philips DuraDiagnost stationary X-ray system
Creator: Philips Electronics North America Corporation
Published: 2015-09-17
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2015-09-17 / Terminated / root cause: labeling and UDI

FDA source

Philips Electronics North America Corporation began a recall of Philips DuraDiagnost stationary X-ray system on 2015-09-17. FDA classified it as Class II and gives the reason as "Buttons or keys on the monitor allow the user to turn the volume setting down to 0", in which case the beep will not be heard at the conclusion of an exposure, as required 21 CFR 1020.31(j), and the Height-Adjustable...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2682-2016
Classification: Class II
Status: Terminated
Initiated: 2015-09-17
Posted: 2016-09-01
Terminated: 2017-08-31
Recalling firm: Philips North America LLC
Product: Philips DuraDiagnost stationary X-ray system
Product code: KPR System, X-Ray, Stationary
Reason for recall: Buttons or keys on the monitor allow the user to turn the volume setting down to 0", in which case the beep will not be heard at the conclusion of an exposure, as required 21 CFR 1020.31(j), and the Height-Adjustable Tabletop is missing the required labels [21 CFR 1010.2., 21 CFR 1010.3(a), and 21 CFR 1020.30(3)].
Root cause tag: labeling and UDI
FDA root cause: Radiation Control for Health and Safety Act
Action: Philips plans to bring the products into compliance with the Federal standard at no cost to customers by implementing a field correction. 1. You will contact customers and initiate the actions to correct the failure to comply issues. 2. You will attach the warning label to maintain an audible volume, and issue a supplement to the user manual that instructs the user how to adjust the volume for the local noise environment and include a warning that the user shall maintain an audible volume. 3. You will attach the identification label to the affected Height-Adjustable Tabletop. 4. The customer notification letter which includes a statement that you will without charge, remedy the defect or bring the product into compliance. If you need any further information or support concerning this, please contact your local Philips representative or Philips Customer Service: 1-800-722-9377.
Quantity in commerce: 15
Distribution: US Distribution to the states of : ME, NE, OR, CA, TX, NC, WA and OH.
Product codes and lots: SN: 140054 140059 150013 150014 150039 150041 150042 150052 150053 150055 150056 150059 150061 150091 150093

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2682-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2682-2016	Class II	Terminated	FDA Mandated	2016-09-07	2016-09-01

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)