Enforcement Report - Week of July 18, 2012
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Event Detail
| Event ID | 62005 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Philips Medical Systems (Cleveland) Inc |
| City | Cleveland |
| State | OH |
| Country | US |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-05-23 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Worldwide Distribution -- Nationwide Distribution including the states of AZ, OR, PA and TX and the countries of Australia, Belgium, Canada, Denmark, Finland, France, Germany, India, Indonesia, Israel, Russia, South Africa, South Korea, Spain, Sweden, Switzerland, and United Kingdom. |
Product Detail
| Product Description | Code Info | Classification | Reason for Recall | Product Quantity | Recall Number |
|---|---|---|---|---|---|
| IntelliSpace Portal software and Extended Brillance Workspace software Intellispace Portal is a multimodality thin-client applications server that delivers full diagnostic viewing and clinical applications to the enterprise. The Philips Extended Brillance Workspace is intended for use as a diagnostic viewing and processing workstation. | Model number: 881001; serial numbers: 85104, 80818, 85088, 82038, 81013, 80911, 82017, 80994, 81021, 81017, 81065, 81161, 81164, 81130, 81004, 81003 & 80979. Model number: 728260; serial numbers: 10102, 6483, 14691, 10155, 12050, 11169, 15016, 15677, 15658, 14834, 14955, 10173, 15018, 14171, 14170, 11994 & 11995. | Class II | The Intellispace Portal software and Extended Brillance Workspace software may have significantly different results in the colors and size of the affected area when the customer uses the "Time Sensitive" and "Time Insensitive" methods. | 38 | Z-1987-2012 |
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