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U.S. Department of Health and Human Services

Enforcement Report - Week of June 20, 2012

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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
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