CA1000 2.0 SP 14Recalls & reported problems
Ge Healthcare · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
4 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 4
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
4 FDA recall records name this device's identifier, 4 still open.
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 16, 2026.
Recalls naming this device
- Feb 19, 2025Open, Classified
There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-IW (PACS-IW), Centricity Radiology RA600 (RA600), & Centricity Cardiology CA1000 (CA1000) where the service login credentials are able to be identified which could allow a malicious actor with these credentials to access the system and potentially manipulate patient data.
Z-1485-2025 · Root cause: Software design · Recall details · FDA record ↗
- Feb 19, 2025Open, Classified
There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-IW (PACS-IW), Centricity Radiology RA600 (RA600), & Centricity Cardiology CA1000 (CA1000) where the service login credentials are able to be identified which could allow a malicious actor with these credentials to access the system and potentially manipulate patient data.
Z-1486-2025 · Root cause: Software design · Recall details · FDA record ↗
- Apr 28, 2022Open, Classified
Potential for Distance and Area measurements to display inaccurate measurement values when performed on magnified images, and specific to ZFP, Distance and Area measurements can display inaccurate measurement values when performed on lossy images that are scaled down from their original resolution.
Z-1231-2022 · Root cause: Software design · Recall details · FDA record ↗
- Apr 28, 2022Open, Classified
Potential for Distance and Area measurements to display inaccurate measurement values when performed on magnified images, and specific to ZFP, Distance and Area measurements can display inaccurate measurement values when performed on lossy images that are scaled down from their original resolution.
Z-1232-2022 · Root cause: Software 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 6.0Ge Healthcare · System, image processing, radiological8 recalls0 reports
- CENTRICITY UNIVERSAL VIEWER ZFP CLIENT 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
- VMA 2Ortho Kinematics, Inc. · System, Image Processing, Radiological4 recalls0 reports
- IntelliSpace Cardiovascular 7Philips Medical Systems Nederland B.V. · System, Image Processing, Radiological2 recalls99 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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