Recall Z-2384-2012 ยท MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Philips Healthcare Inc.
Philips DigitalDiagnost Systems with M Cabinet Model: 712025 Stationary radiographic system, digital-Universal RAD Applications
| Date | Sep 14, 2012 (initiated Aug 14, 2012) |
| Status | Terminated |
| Reason | Creepage Distance between the two primary phases in the GEO Transformer is 4.5 mm.does not meet (IEC) International standard of 5.5 mm. |
| Root cause | Device Design |
| Action | Philips Healthcare Imaging issued an Urgent - Field Safety Notice dated August 8, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. The unit will be exchanged with a new unit that complies with the IEC requirements. Please reference Field Change Order (FCO) 71200081 when contacting I your local Philips representative. 1-800-722-9377. Customer were instructed to review the information contained in the letter with all members of their staff who need to be aware of the contents of the letter and to maintain a copy of the |
| Quantity | 4 systems |
| Distribution | Worldwide Distribution - USA including OH and WA and the country of Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K982795 | PHILIPS BUCKY VISION Philips Medical Systems, Inc., Nov 24, 1998 |