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.
Enforcement
- Recall Number
- Z-1964-2013
- Event ID
- 65839
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Philips Healthcare Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- August 28, 2013
- Initiation Date
- June 11, 2013
- Classification Date
- August 20, 2013
- Termination Date
- January 12, 2017
- Address
- 3000 Minuteman Road, N/A, Andover, MA, 01810, United States
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.
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).
System Code - 712001
US Nationwide Distribution including Puerto Rico
240 systems US -- 1 system within Puerto Rico