Z-1964-2013Class II

Philips Healthcare MobileDiagnostwDR system. Mobile Digital radiography X-Ray System

Name: Z-1964-2013 Philips Healthcare MobileDiagnostwDR system. Mobile Digital radiography X-Ray System
Creator: Philips Healthcare Inc.
Published: 2013-06-11
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2013-06-11 / Terminated / root cause: labeling and UDI

FDA source

Philips Healthcare Inc. began a recall of Philips Healthcare MobileDiagnostwDR system. Mobile Digital radiography X-Ray System Product Usage: MobileDiagnost wDR is a mobile digital radiography X-Ray... on 2013-06-11. FDA classified it as Class II and gives the reason as "The Instructions for Use (IFU) for the MobileDiagnost wDR fails to comply with a Federal standard. The IFU does not provide tolerance levels for several generator values as required by 1020.30(h)(3)". 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-1964-2013
Classification: Class II
Status: Terminated
Initiated: 2013-06-11
Posted: 2013-08-21
Terminated: 2017-01-12
Recalling firm: Philips North America LLC
Product: Philips Healthcare MobileDiagnostwDR system. Mobile Digital radiography X-Ray System Product Usage: MobileDiagnost wDR is a mobile digital radiography X-Ray System. It is intended for use by a qualified/trained doctor or technologist on both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with patient sitting, standing, or lying in the prone or supine positions. Not intended for mammography.
Product code: IZL System, X-Ray, Mobile
Reason for recall: The Instructions for Use (IFU) for the MobileDiagnost wDR fails to comply with a Federal standard. The IFU does not provide tolerance levels for several generator values as required by 1020.30(h)(3).
Root cause tag: labeling and UDI
FDA root cause: Radiation Control for Health and Safety Act
Action: Phillips Healthcare sent an Important Notification letter dated July 10, 2013 to all affected customer. The notification informed customers that Philips will implement an update to the Instruction for Use (IFU). Philips will, without charge, remedy the defect or bring the product into compliance with each applicable Federal standard in accordance with a plan to be approved by the Secretary of Health and Human Services. For questions contact your local Philips representative or local Philips Healthcare office.
Quantity in commerce: 240 systems US -- 1 system within Puerto Rico
Distribution: US Nationwide Distribution including Puerto Rico
Product codes and lots: System Code - 712001

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1964-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1964-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-28	2013-08-20

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)