PCR Eleva Radiological Image Processing System with software R.1.2 Philips Healthcare, Inc. A computed radiography image
FDA device recall Z-3205-2011 · posted 2011-09-14 · Terminated
Recall details
- Recalling firm
- Philips Healthcare Inc.
- Reason for recall
- 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
- Action taken
- 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 install improved software that prevents the misinterpretation of the symbol and will schedule the installation of the updated software. For questions on this recall call Phillips Healthcare Inc. at 978-687-1501.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 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, Cr
- Date initiated
- 2011-07-27
- Date posted
- 2011-09-14
- Date terminated
- 2017-01-12
- Location
- Andover, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PHILIPS COMPUTED RADIOGRAPHY (K964124) | Philips Medical Systems, Inc. | 1996-12-18 |