Z-1555-2015Class II

Philips Healthcare DuraDiagnost X- Ray

Name: Z-1555-2015 Philips Healthcare DuraDiagnost X- Ray
Creator: Philips Medical Systems, Inc.
Published: 2015-02-09
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2015-02-09 / Terminated / root cause: software

FDA source

Philips Medical Systems, Inc. began a recall of Philips Healthcare DuraDiagnost X- Ray on 2015-02-09. FDA classified it as Class II and gives the reason as "The system is designed to emit a beep upon termination of an exposure. However, if the system has been powered on for over 12 hours, the system will no longer emit this signal. This is a failure to comply with 21CFR...". 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-1555-2015
Classification: Class II
Status: Terminated
Initiated: 2015-02-09
Posted: 2015-05-19
Terminated: 2016-06-14
Recalling firm: Philips North America LLC
Product: Philips Healthcare DuraDiagnost X- Ray
Product code: KPR System, X-Ray, Stationary
Reason for recall: The system is designed to emit a beep upon termination of an exposure. However, if the system has been powered on for over 12 hours, the system will no longer emit this signal. This is a failure to comply with 21CFR 1020.31(j).
Root cause tag: software
FDA root cause: Software design (manufacturing process)
Action: Philips Healthcare Planned action: 1. Philips healthcare will contact customers and initiate a software update to correct the software deficiency causing the problem. 2. Philips engineers will install the software. 3. Philips engineers will perform testing to ensure the software update was effective. 4. Corrections are to be made free of charge 5. Corrective actions should be completed by August 15, 2015 For further questions call (978) 659-7892
Quantity in commerce: 3 DuraDiagnost
Distribution: Worldwide Distribution - Nationwide Distribution and the countries of Australia, Austria, Argentina, Canada, China, Chile, Colombia Czech Republic, Great Britain, Germany, Egypt, Finland, France, India, Ireland, Japan, Malaysia, Macedonia, Mexico, Netherlands, New Zealand, Nepal, Peru, Poland, Russia, Saudi Arabia Singapore, Switzerland, Sweden, Spain, United Arab Emirates and United Kingdom.
Product codes and lots: DuraDiagnost Stationary X-ray System.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1555-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1554-2015	Class II	Terminated	Voluntary: Firm initiated	2015-05-27	2015-05-21
Z-1555-2015	Class II	Terminated	Voluntary: Firm initiated	2015-05-27	2015-05-21

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)