Z-2154-2017Class II

Philips DigitalDiagnost 3.1.x X-Ray System

Name: Z-2154-2017 Philips DigitalDiagnost 3.1.x X-Ray System
Creator: Philips Electronics North America Corporation
Published: 2017-05-11
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2017-05-11 / Terminated / root cause: software

FDA source

Philips Electronics North America Corporation began a recall of Philips DigitalDiagnost 3.1.x X-Ray System on 2017-05-11. FDA classified it as Class II and gives the reason as "During recent evaluations of the Philips DigitalDiagnost 3.1.x, we have identified a potential issue that may affect the performance of the equipment under certain conditions". 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-2154-2017
Classification: Class II
Status: Terminated
Initiated: 2017-05-11
Posted: 2017-06-09
Terminated: 2018-07-10
Recalling firm: Philips North America LLC
Product: Philips DigitalDiagnost 3.1.x X-Ray System
Product code: MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Reason for recall: During recent evaluations of the Philips DigitalDiagnost 3.1.x, we have identified a potential issue that may affect the performance of the equipment under certain conditions.
Root cause tag: software
FDA root cause: Software design
Action: Philip's planned action to bring defect into compliance: 1. You will contact customers and initiate a software update to correct the issue that incorrectly notifies the user of the detectors being ready. 2. You will install the software/firmware and perform testing to ensure the software update was effective. 3.You will provide a customer notification letter that includes a statement that you will without charge, remedy the defect or bring the product into compliance. CDRH approves the CAP subject to the following conditions: 1. Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) district office coordinator noted below are to be included in the notification. 2.Philips Healthcare will implement this CAP by November 10, 2017. If you need any further information or support concerning this Issue, please contact your local Philips representative: Technical Support Line: 1-800-722-9377. We apologize for any inconvenience this may cause and trust that this information is adequately addressing any concerns you may have.
Quantity in commerce: US - 132
Distribution: USA(nationwide) Distribution to the states of : AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KY, LA, MA, ME, MI, MN, MO, NC, ND, NE, NH, NM, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA and WI
Product codes and lots: DigitalDiagnost Upgrade Release 3.1.x to 3.1.3

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2154-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2154-2017	Class II	Terminated	FDA Mandated	2017-06-21	2017-06-09

Product code MQB

K141736Class IIPhilips Prograde; Philips Eleva Workspot for Digital DiagnostPhilips Medical Systems Dmc GmbH / cleared 2014-07-25

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)