Recall Z-2494-2012 ยท MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Philips Healthcare Inc.
Philips Digital Diagnost with patient carriage Model: 712050 with serial number range from 00 000 00 to 09 000 543. Product Usage: Stationary radiographic System
| Date | Sep 28, 2012 (initiated Sep 12, 2012) |
| Status | Terminated |
| Reason | Hook does not securely hold the footplate in vertical position, causing the footplate to disengage and may fall on patient or operator |
| Root cause | Device Design |
| Action | Philips Healthcare sent an Urgent Field Safety Notice letter dated August 15, 2012 to all affected customers. The letter identified the affected product, problem and the actions to be taken to avoid or minimize the occurrence of the issue. Customers were advised to follow the instruction for Use and that Philips plans to replace the old hook with one that has a new design. For questions contact your local Philips representative 1-800-722-9377. |
| Quantity | 536 units |
| Distribution | Worldwide Distribution - US Nationwide and the countries of :Australia, Austria, Bahrain, Belgium, Canada, Chile, China, Czech Republic, Denmark, Finland, , France, Germany, Ireland, Italy, Japan, Netherlands, New Zealand, Norway, Poland, Qatar, Romania, Russia, Saudi Arabia, Sweden, Slovakia, South |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K982795 | PHILIPS BUCKY VISION Philips Medical Systems, Inc., Nov 24, 1998 |