Z-1503-2014Class II

Digital Diagnost, stationary radiographic system; Models: 712020/22/25/26/50/52/54/55/57/60/62/80/81/82/85

Name: Z-1503-2014 Digital Diagnost, stationary radiographic system; Models: 712020/22/25/26/50/52/54/55/57/60/62/80/81/82/85
Creator: Philips Medical Systems, Inc.
Published: 2014-03-17
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2014-03-17 / Terminated / root cause: manufacturing process

FDA source

Philips Medical Systems, Inc. began a recall of Digital Diagnost, stationary radiographic system; Models: 712020/22/25/26/50/52/54/55/57/60/62/80/81/82/85 on 2014-03-17. FDA classified it as Class II and gives the reason as "The footboard of Patient support for stitching can be fixed in upper position. When the fix clamp (hook) is not correctly adjusted into its correct position, the footboard is not securely held". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1503-2014
Classification: Class II
Status: Terminated
Initiated: 2014-03-17
Posted: 2014-04-24
Terminated: 2020-09-16
Recalling firm: Philips North America LLC
Product: Digital Diagnost, stationary radiographic system; Models: 712020/22/25/26/50/52/54/55/57/60/62/80/81/82/85
Product code: MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Reason for recall: The footboard of Patient support for stitching can be fixed in upper position. When the fix clamp (hook) is not correctly adjusted into its correct position, the footboard is not securely held.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On March 17, 2014, consignees were notified of the recall via letter. The letter explains what the issue is, actions firms can take to avoid or minimize the occurrence of the issue, and the actions planned by Philips to correct the issue. For further information or support concerning this issue, please contact your local Philips Representative. 1-800-722-9377
Quantity in commerce: 985 devices
Distribution: Nationwide: US: AL, AR, AZ, CA, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, MA, MD, ME, MN, MO, MS, MT, NC, ND, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, WY / Worldwide including Canada & Mexico
Product codes and lots: Units distributed from November 2006 through March 2014.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1503-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1503-2014	Class II	Terminated	Voluntary: Firm initiated	2014-04-30	2014-04-24

Product code MQB

K982795Class IIPhilips Bucky VisionPhilips Medical Systems, Inc. / cleared 1998-11-24

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)