Enforcement Report - Week of June 20, 2012
-
Back to Previous Page
Product Detail
| Product Description | Philips Healthcare Practix Convenio Mobile X-ray system Worldwide Distribution -- Nationwide |
|---|---|
| Recall Number | Z-1538-2012 |
| Classification | Class II |
| Code Info | n/a |
| Product Distributed Qty | 11 - US |
| Reason For Recall | 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. |
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 |
-
