Philips IntelliSpace PACS 4.4 image management systems performs digital image processing, measurement and communication
FDA device recall Z-2252-2014 · posted 2014-08-16 · Terminated
Recall details
- Recalling firm
- Philips Healthcare Informatics, Inc.
- Reason for recall
- A problem was detected in the Philips IntelliSpace PAC 4.4 software where if patient information is changed in the DICOM header and the study is exported before the image is updated in the PACS, the unchanged data may export causing the potential for diagnosis on incomplete data.
- Action taken
- Urgent Medical Device Correction was sent to all affected sites on July 24, 2014 by certified mail.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 109 units
- Distribution
- US and Australia, Belgium, Canada, Egypt, France, Germany, Netherlands, Oman, Saudi Arabia, Spain, Switzerland, United Arab Emirates, United Kingdom.
- Date initiated
- 2014-07-24
- Date posted
- 2014-08-16
- Date terminated
- 2016-02-11
- Location
- Foster City, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INTELLISPACE PACS 4.X (K111804) | Philips Healthcare Informatics, Inc. | 2011-07-28 |