—#104359

Product

Philips BV Pulsera Fluoroscopic Image Intensified X-ray Catalog Number: 718095 Product Usage: Fluoroscopic x-ray system, image-intensified Fluoroscopic x-ray system.

FDA product code: JAA — System, X-Ray, Fluoroscopic, Image-Intensified
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K010435
Affected lot / code info: Shipped from May 2010 to 26 Jul 2011. S/N: 774 1463 1492 1568 1572 1597 1598 1599 1600 1601 1603 1604 1605 1606 1607 1608 1609 1615 1616 1620 1634 1648 1649 1650 1654 1655 1656 1657 1658 1659 1660 1661 1662 1663 1677 1679 1681 1682 1703 1709 1710 1711 1712 1713 1726 1727 1731 1732 1734 1735 1736 1741 1742 1743 1744 1745 1746 1758 1783 1784 1797 1818 1819 1826 1827 1831 1848 1857 1858 1859 1865 1866 1867 1868 1869 1872 1885 1894 1898 1900 1903 1908 1919 1922 1930 1931 1936 1937 1938 1946 1950 1951 1955 1956 1959 1965 1966 1967 1968 1970 1979 1980 1981 1982 1983 1984 1986 1987 1988 1989 1990 1991 1992 1998 1999 2000 2003 2005 2012 2016 2017 2018 2020 2021 2022 2025 2042 2043 2044 2046 2064 2074 2075

Why it was recalled

Front plate broke in to two pieces causing the C-Arm to suspend on the single central bolt

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

Philips Healthcare Inc., sent an "URGENT - Field Safety Notice" dated September 30, 2011 to all affected customers. The notice identifies the following: what the problem is and under what circumstances it can occur; the actions that should be taken by the customer/user in order to prevent risks for patients or users and the actions planned by Philips Medical Systems to correct the problem. The notice contains important information for the continued safe and proper use of the equipment and customers were advised to retain a copy with the equipment Instruction for Use. The notice stated that Philips will replace the front plates for systems on the Unit Affected List by the end of June 2012. The notice instructed customers to contact Philips Healthcare representative for further information or support.

Recalling firm

Firm: Philips Healthcare Inc.
Address: 3000 Minuteman Road, Andover, Massachusetts 01810

Distribution

Distribution pattern: Worldwide Distribution - USA (nationwide) and the countries of: Australia, Austria, Belgium, Bharain, Canada, Croatia, Denmark, France, Germany, Greece, Italy, Japan, Netherlands, Norway, Portugal, Russian Fed., Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, and United Kingdom.

Timeline

Recall initiated: 2011-10-04
Posted by FDA: 2011-10-27
Terminated: 2017-01-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #104359. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.