Z-0269-2014 Class II Terminated
FDA device recall Z-0269-2014 was initiated by Philips Healthcare Informatics, Inc. on October 14, 2013 and is designated Class II. Reason for recall: 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 addit… The recall status is terminated (terminated June 11, 2014). Affected quantity: 71 units.
Recall Details
- Product Type
- Devices
- Report Date
- November 20, 2013
- Initiation Date
- October 14, 2013
- Termination Date
- June 11, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 71 units
Product Description
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 for Recall
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.
Distribution Pattern
Worldwide Distribution - USA (nationwide) and country: Canada.
Code Information
All units of these IntelliSpace PACS.