iSite PACS image management system; Picture Archiving and Communications System; Radiology software package, Philips Hea
FDA device recall Z-1141-2008 · posted 2008-05-08 · Terminated
Recall details
- Recalling firm
- Philips Healthcare Informatics, Inc.
- Reason for recall
- Incorrect display of one of the patient's images. This malfunction could cause an image to be incorrectly displayed, for example flipped left to right and anterior to posterior. The original image is still presented in the correct orientation next to the incorrect image when displayed on the monitor.
- Action taken
- Philips Healthcare Informatics mailed customers notification: Urgent Product Correction regarding FCO#2954704-01/04/08-001-C. Firm released a corrected version of software (iSite PACS v.3.5.69) on January 21, 2008. Firm is scheduling customers to upgrade to the corrected version.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 197 units
- Distribution
- Worldwide Distribution: USA, United Arab Emirates, Germany, the Netherlands, Denmark, Australia, France, Italy, Belgium, Ireland, Italy, and Canada.
- Date initiated
- 2008-01-04
- Date posted
- 2008-05-08
- Date terminated
- 2009-10-07
- Location
- Foster City, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ISITE PACS (K042292) | Stentor, Inc. | 2004-09-08 |