iSite PACS with iSite ViewForum Applications, R7.4V6 L1 L2, L3, Versions: 3.6.96, 3.6.101, 3.6.110, 4.1.96, 4.1.101, and
FDA device recall Z-1882-2011 · posted 2011-04-04 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems
- Reason for recall
- A software anomaly that occurs when clinicians use Volume Vision to view images in 3D and uses the measurement tool to measure regions of interest. This could lead to an incorrect interpretation of the measurements which could cause an incorrect diagnosis and incorrect treatment plan.
- Action taken
- Philips sent an Urgent Field Safety Notice letter dated February 23, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to assure that all colleagues were aware of the problem. When using the Volume Vision software, check the correctness of measurements (graphics and numerical values) prior to saving a captured image containing measurements. Save captured images containing measurements immediately after creating them and before altering the measurements in the original image view. For any subsequent measurements, create a new capture and save it immediately. For further information or support concerning this issues, customers should contact their local Philips representative at +1-877-328-2808.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LLC
- Distribution
- Worldwide Distribution.
- Date initiated
- 2011-02-23
- Date posted
- 2011-04-04
- Date terminated
- 2011-08-18
- Location
- Foster City, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PHILIPS VIEWFORUM 2003 (K032096) | Philips Medical Systems | 2003-07-18 |