Recall Z-1964-2013 ยท IZL System, X-Ray, Mobile
Philips Healthcare Inc.
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. A
| Date | Aug 21, 2013 (initiated Jun 11, 2013) |
| Status | Terminated |
| 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). |
| Root cause | Radiation Control for Health and Safety Act |
| Action | 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. |
| Quantity | 240 systems US -- 1 system within Puerto Rico |
| Distribution | US Nationwide Distribution including Puerto Rico |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K111725 | MOBILEDIAGNOST WDR Sedecal., Sa., Jul 19, 2011 |