iSite PACS (Picture Archiving and Communications System) Versions 4.1.x up to and including 4.1.51.3, manufactured by Ph
FDA device recall Z-0948-2009 · posted 2009-01-30 · Terminated
Recall details
- Recalling firm
- Philips Healthcare Informatics, Inc.
- Reason for recall
- Product may display clinical reports with the study date and time in GMT format, which may not be obvious to the end user, who may expect to see the local time in the report.
- Action taken
- Product notification was issued on 12/29/2008, instructing users to identify affected products, and instructing users to refer to image overlays for local study date and time information. The firm is planning a field correction expected to be available in "Q1 2009". For additional information, contact Philips at 650-293-2624.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 40 units
- Distribution
- International - Italy, Denmark, Germany, Netherlands, Sweden, Spain, Portugal, Switzerland, Spain, Turkey, France, Saudi Arabia, Australia, Thailand, New Zealand, Japan, and Brazil.
- Date initiated
- 2008-12-29
- Date posted
- 2009-01-30
- Date terminated
- 2010-11-29
- Location
- Foster City, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ISITE PACS, V 4. X (K063267) | Stentor Inc., A Philips Medical Systems Co. | 2006-11-09 |