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Philips Healthcare Informatics Recalls
4 recalls on record · November 20, 2013 to June 17, 2020 · Medical Devices
Recalls by year
13
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20
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
June 17, 2020Medical DevicesFDA
Philips Healthcare Informatics, Inc. recalls IntelliSpace PACS 4.4, Product number 837507 - Product Usage: intended to be used by trained professionals, including bu
Hazard: Images may potentially become corrupt while using the system.
August 27, 2014Medical DevicesFDA
Philips Healthcare Informatics, Inc. recalls Philips IntelliSpace PACS 4.4 image management systems performs digital image processing, measurement and communication
Hazard: A problem was detected in the Philips IntelliSpace PAC 4.4 software where if patient information is changed in the DICOM header and the study is exported before the image is updated in the PACS, the unchanged data may export causing the potential for diagnosis on incomplete data.
May 28, 2014Medical DevicesFDA
Philips Healthcare Informatics, Inc. recalls Philips XRE, the dictation editor system included in the Philips XIRIS 8.1.50 XIRIS is a radiology information system
Hazard: When using XIRIS Rio version (8.1.50.0) in conjuncture with iSite PACS a synchronization error can occur and if not noticed, information for the incorrect patient may be displayed
November 20, 2013Medical DevicesFDA
Philips Healthcare Informatics, Inc. recalls Philips brand IntelliSpace PACS 4.4, Image Management System; The system is a software package used with general purpose
Hazard: Philips Healthcare became aware of a software problem with the IntelliSpace PACS system, in that a timing issue has been identified that may result in a condition where the device does not store additional images received before processing is complete. The missing images may contain pathology which may result in a different diagnosis if they had been available at time of interpretation.