Recall Z-3205-2011 ยท LLZ System, Image Processing, Radiological
Philips Healthcare Inc.
PCR Eleva Radiological Image Processing System with software R.1.2 Philips Healthcare, Inc. A computed radiography image processing system.
| Date | Sep 14, 2011 (initiated Jul 27, 2011) |
| Status | Terminated |
| Reason | The mirror icon on the bottom of each image could be interpreted as a RIGHT marker for side indication if the image is mirrored again within a PACS system. This could potentially lead to a misdiagnosis |
| Root cause | Software design |
| Action | Philips Healthcare Inc. sent out "Urgent --Medical Device Correction" notices dated June 10, 2011 to all affected customers. The letter described the product and problem. Customers were informed the "burned-in Mirror-Icon" may be misinterpreted as a Right marker. Customers are advised to preferably use lead markers during each X-ray acquisition or alternatively electronic annotations on each image for side indication. The presentation of these markers within each image will clearly show the difference between the intended Left/Right indication and the little mirror ICON. Philips will ins |
| Quantity | 197 units |
| Distribution | Worldwide Distribution: Nationwide distribution; and including the countries of Albania, Angola, Argentina, Australia, Austria, Azerbaijan, Belgium, Bolivia, Brazil, Bulgaria, Canada, Chile, China, Croatia, Denmark, Egypt, France, Germany, Ghana, Greece, Greece, Haiti, Hungary, Indonesia, Iraq, Isr |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K964124 | PHILIPS COMPUTED RADIOGRAPHY Philips Medical Systems, Inc., Dec 18, 1996 |