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U.S. Department of Health and Human Services

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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