Enforcement Report - Week of March 13, 2013
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Product Detail
| Product Description | Philips Digital Diagnost Stationary radiographic system |
|---|---|
| Recall Number | Z-0900-2013 |
| Classification | Class II |
| Code Info | All Digital Diagnost systems with Eleva software version 3.0.x |
| Product Distributed Qty | 360 |
| Reason For Recall | When the operator for a wall stand view selects an "image rotation" different from default, or such image rotation is preset in the examination database, then the resulting image may be rotated in the wrong direction. When the operator manually rotates the image back, electronic side markers (if programmed) are rotated also and as a result may be placed in a wrong position inside the image. |
Event Detail
| Event Id | 63671 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Philips Healthcare Inc. |
| City | Andover |
| State | MA | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-10-30 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Worldwide Distribution - USA (nationwide) and Internationally to Argentina, Australia, Austria, Canada, Chile, Czech republic, Estonia,France, Germany, Hungary, Inida, Ireland, Italy, Japan, Libyan Arab Jamahari, Mexico, Netherlands, New Zealand, Norway , Oman, Panama, Peru, Poland, Qatar, Reunion, Russia, Saudi Arabia, South Africa, South Korea,Spain, Sweden, Swizerland, Thailand, UAE, and the UK. |
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