Z-1706-2017Class II

Mobile Diagnostic X-Ray System with Digital Panel

Name: Z-1706-2017 Mobile Diagnostic X-Ray System with Digital Panel
Creator: Philips Healthcare Inc.
Published: 2012-11-28
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2012-11-28 / Terminated / root cause: software

FDA source

Philips Healthcare Inc. began a recall of Mobile Diagnostic X-Ray System with Digital Panel on 2012-11-28. FDA classified it as Class II and gives the reason as "When the operator moves an image to another view then the electronic marker might be placed at the wrong anatomical position in the resulting image". 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-1706-2017
Classification: Class II
Status: Terminated
Initiated: 2012-11-28
Posted: 2017-04-04
Terminated: 2018-05-31
Recalling firm: Philips North America LLC
Product: Mobile Diagnostic X-Ray System with Digital Panel
Product code: IZL System, X-Ray, Mobile
Reason for recall: When the operator moves an image to another view then the electronic marker might be placed at the wrong anatomical position in the resulting image.
Root cause tag: software
FDA root cause: Software design
Action: Philips Medicals Systems distributed an "URGENT Field Safety Notice" alerting customers of the defect on November 28, 2012. Customers are requested to manually rotate images by using the rotation tool.Customers are also recommended to check whether the automatic marker is set correctly, especially after a manual image rotation is performed. The marker can be corrected manually with the annotation tool.
Quantity in commerce: 220 systems
Distribution: Nationwide (AR, AZ, CA, DE, FL, GA, IA, IL, IN, KS, MD, MI, MN, NC, NM, NY, OH, OR, PA, SC, TX, VT, WI)
Product codes and lots: *** All units ***

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1706-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1706-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-12	2017-04-04

Product code IZL

K111725Class IIMobilediagnost WdrSedecal., Sa. / cleared 2011-07-19

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)