Reported Nov 20, 2013 · Terminated
Philips brand IntelliSpace PACS 4.4, Image Management System; The system is a software package used with general…
Philips Healthcare Informatics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Philips Healthcare Informatics, Inc. · 4100 E 3rd Ave Ste 101 · Foster City, CA · 94404-4819
Is this the product you have?
- 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 DICOMCT, MR, NM, US, XA, PET, DX, DR, RE, RT, MG, SC, VL, as well as hospital/radiology information systems
- Lot codes and dates
- All units of these IntelliSpace PACS.
- Amount recalled
- 71 units
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Philips Healthcare Informatics, Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.