Enforcement Report - Week of June 27, 2012
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Event Detail
| Event ID | 61877 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Philips Healthcare Inc. |
| City | Andover |
| State | MA |
| Country | US |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-05-11 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | 6 US customers |
Product Detail
| Product Description | Code Info | Classification | Reason for Recall | Product Quantity | Recall Number |
|---|---|---|---|---|---|
| Philips Easy Diagnost Product Usage: Stationary Fluoroscopic system | All systems with Eleva software version 4.x and stitching option. | Class II | If a lead ruler is not positioned in the same plane as the anatomical image detail to be measured, measured object distances (using the ruler) can be wrong by a corresponding factor. If, additionally, the measurement tool is not used to check the ruler, or is used in the right way (ie: calibration), such calibration error is not detected. As a result of this, a surgical intervention may be executed unnecessarily. Usability is identified to be the main contributing factor. | 6 | Z-1821-2012 |
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