IntelliSpace PACS IntelliSpace PACS - 4Recalls & reported problems
Philips Healthcare Informatics, Inc. · IntelliSpace PACS is an image management system 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. Lossy compressed mammographic images and digitized screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Recalls naming this device
- Apr 19, 2019Class IICompleted
Images may potentially become corrupt while using the system.
Z-2338-2020 · Root cause: Device Design · Recall details · FDA record ↗
Other System, image processing, radiological devices
- Interventional Workspot Interventional Workspot - 1Philips Medical Systems Nederland B.V. · System, Image Processing, Radiological13 recalls24 reports
- Synapse Radiology PACS Synapse Radiology PACS Software LicenseFujifilm Healthcare Americas Corporation · System, image processing, radiological9 recalls38 reports
- CENTRICITY UNIVERSAL VIEWER ZFP CLIENT 6.0Ge Healthcare · System, image processing, radiological8 recalls0 reports
- CENTRICITY UNIVERSAL VIEWER 6.0Ge Healthcare · System, image processing, radiological8 recalls0 reports
- CENTRICITY UNIVERSAL VIEWER 7.0Ge Healthcare · System, image processing, radiological6 recalls0 reports
- IntelliSpace Cardiovascular 8Philips Medical Systems Nederland B.V. · System, Image Processing, Radiological2 recalls132 reports
- CA1000 2.0 SP 14Ge Healthcare · System, image processing, radiological4 recalls0 reports
- VMA 2Ortho Kinematics, Inc. · System, Image Processing, Radiological4 recalls0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page