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Terminated

PCR Eleva Radiological Image Processing System with software R.1.2 Philips Healthcare, Inc. A computed radiography image processing system.

FDA Recall Z-3205-2011 · Posted 2011-09-14

Recalling FirmPhilips Healthcare Inc.
Recall StatusTerminated
Product CodeLLZ
Date Initiated2011-07-27
Date Terminated2017-01-12
Product Quantity197 units

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

Firm 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 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

Distribution Pattern

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, Israel, Italy, Kazakhstan, Kenya, Latvia, Libya, Liechtenstein, Lithuania, Malawi, Malta, Martinique, Mexico, Mozambique, Netherlands, New Zealand, Nigeria, Norway, Oman, Philippines, Portugal, Puerto Rico, Romania, Russia, Saudi-Arabia, Serbia, Slovakia, South Africa, Spain, Sudan, Sweden, Switzerland, Tanzania, Thailand, Tschech. Rep, Turkey, Turkmenistan, UAE, Uganda, and United Kingdom.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K964124PHILIPS COMPUTED RADIOGRAPHYPhilips Medical Systems, Inc. · 1996-12-18

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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