Device 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.
Z-1964-2013
Product summary
- Event
- Event 65839
- Status
- Terminated
- Classification
- Class II
- Quantity
- 240 systems US -- 1 system within Puerto Rico
- Official record key
device-enforcement:Z-1964-2013
Official wording
Reason: 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).
Code information: System Code - 712001
Distribution pattern: US Nationwide Distribution including Puerto Rico
Derived failure modes
-
Unknown
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).