Philips Healthcare Inc.: Medical Device Recall in 2013 - (Recall #: Z-1964-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: June 11, 2013

Date Posted: August 28, 2013

Recall Number: Z-1964-2013

Event ID: 65839

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).

Status: Terminated

Product Quantity: 240 systems US -- 1 system within Puerto Rico

Code Information:

System Code - 712001

Distribution Pattern:

US Nationwide Distribution including Puerto Rico

Voluntary or Mandated:

Voluntary: Firm initiated