Recall Z-1538-2012 ยท IZL System, X-Ray, Mobile
Philips Healthcare Inc.
Philips Healthcare Practix Convenio Mobile X-ray system Worldwide Distribution -- Nationwide
| Date | Jun 13, 2012 (initiated Oct 19, 2011) |
| Status | Terminated |
| Reason | When the system is switched off or when the tube arm is parked in the down position (X-ray generator switch off), a radiation pulse (50 kV, 2.5 pGy) is generated inadvertently. .When the system is switched off or when the tube arm is parked in the down position (X-ray generator switch off), a radiation pulse (50 kV, 2.5 pGy) is generated inadvertently. The failure happened when component supplie |
| Root cause | Radiation Control for Health and Safety Act |
| Action | Philips Healthcare sent a proprosed corrective action letter dated May 3, 2012, to FDA. The proposed corrective action plan is to bring the product into compliance with regulatory requirements by issuing a field corrective action which should be completed by Philips by August 1, 2012. For questions regarding this recall call 978-687-1501. |
| Quantity | 11 - US |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.