Enforcement Report - Week of June 20, 2012
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Event Detail
| Event ID | 61830 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Philips Healthcare Inc. |
| City | Andover |
| State | MA |
| Country | US |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2011-10-19 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Nationwide Distribution |
Product Detail
| Product Description | Code Info | Classification | Reason for Recall | Product Quantity | Recall Number |
|---|---|---|---|---|---|
| Philips Healthcare Practix Convenio Mobile X-ray system Worldwide Distribution -- Nationwide | n/a | Class II | When the system is switched off or when the tube arm is parked in the down position (X-ray generator switch off), a radiation pulse (50 kV, 2.5 pGy) is generated inadvertently. .When the system is switched off or when the tube arm is parked in the down position (X-ray generator switch off), a radiation pulse (50 kV, 2.5 pGy) is generated inadvertently. The failure happened when component supplier used a different supplier for a specific integrated circuit "IC" (switched from Philips to Texas Instruments). On a specific control board, called PSM1 8 "CONTROL LOGIC BATTERY", the IC from Texas Instruments is showing an unwanted behavior and is issuing an incorrect Peak Signal of 2.2Vmax. This signal is enough to trigger the X-Ray exposure. | 11 - US | Z-1538-2012 |
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