Recall Z-0269-2014— Philips Healthcare Informatics, Inc.

Class II FDA medical device recall by Philips Healthcare Informatics, Inc., initiated 2013-10-14, terminated 2014-06-11. FDA's recall record names no specific 510(k) clearance for this event. Product: Philips brand IntelliSpace PACS 4.4, Image Management System; The system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. Product is manufactured and distributed by Philips Healthcare Informatics, Inc. Foster City, CA IntelliSpace PACS are image management systems intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. The system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital image processing, measurement, communication and storage. iSite supports receiving, sending, printing, storing and displaying studies received from the following modality types via DICOM: CT, MR, NM, US, XA, PET, DX, DR, RE, RT, MG, SC, VL, as well as hospital/radiology information systems.. Reason: 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..

Recalling firm

Philips Healthcare Informatics, Inc.

Classification

Class II

Status

Terminated

Initiated

2013-10-14

Terminated

2014-06-11

Firm location

Foster City, CA, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.