Recall Z-2059-2013 ยท KPR System, X-Ray, Stationary
Philips Healthcare Inc.
Philips Easy Upgrade DR, Code No: 712086 This system is used for making X-Ray exposures for diagnostics.
| Date | Aug 26, 2013 (initiated Aug 8, 2013) |
| Status | Terminated |
| Reason | The mirror icon on the bottom of each image could be misinterpreted as a RIGHT lead marker for side indication if the image is mirrored within a PACS system. |
| Root cause | Software design |
| Action | Philips Healthcare sent an Urgent Field Safety Notice letter dated July 24, 2013, to all affected customer. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed : When reading an image, a physician should not use the mirror icon for image side interpretation. 2. Clinical staff should follow the Instructions for Use and use lead letters to indicate body orientation of patient or equivalent electronic markers to provide Left/Right indications, during all X-ray image acquisitions. Philips will upgrade the system, which i |
| Quantity | 89 |
| Distribution | Worldwide Distribution - US Nationwide including the states of AZ, CA, CO, DE, FL, GA, MO, MS, NC, NH, NY, PA and TX., and the countries of Canada, Australia, China, Czech Republic, France, Germany, Greece, Italy, Netherlands, Portugal, Russia, Saudi Arabia, Slovenia, Spain, Sweden, Switzerland, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K982795 | PHILIPS BUCKY VISION Philips Medical Systems, Inc., Nov 24, 1998 |