—#120442

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.

FDA product code: IZL — System, X-Ray, Mobile
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K111725
Affected lot / code info: System Code - 712001

Why it was recalled

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 (FDA determination)

Radiation Control for Health and Safety Act

Action the firm took

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.

Recalling firm

Firm: Philips Healthcare Inc.
Address: 3000 Minuteman Road, Andover, Massachusetts 01810

Distribution

Distribution pattern: US Nationwide Distribution including Puerto Rico

Timeline

Recall initiated: 2013-06-11
Posted by FDA: 2013-08-21
Terminated: 2017-01-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #120442. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.