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.
This recall has been terminated (originally issued August 21, 2013).
- Company
- Philips Healthcare Inc.
- Recall Initiated
- June 11, 2013
- Posted
- August 21, 2013
- Terminated
- January 12, 2017
- Recall Number
- Z-1964-2013
- Quantity
- 240 systems US -- 1 system within Puerto Rico
- Firm Location
- Andover, MA
- Official Source
- View on FDA website ↗
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).
Distribution
US Nationwide Distribution including Puerto Rico
Lot / Code Info
System Code - 712001
Root Cause
Radiation Control for Health and Safety Act
Action Taken
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.