—#72469

Product

Motorized Height Ceiling Suspensions (MCS) and motorized height movement (actuator) for X-ray systems. Usage: Ceiling suspension unit with an actuator to hold monitors and X-ray shields.

FDA product code: IZI — System, X-Ray, Angiographic
Device class: Class 2
Medical specialty: Radiology
Affected lot / code info: Products are identified as Equipment numbers: 13046, 25934, 34702, 38592, 41455, 44791, 45059, 52463, 62671, 82824, 83667, 85095, 85137, 85190, 85195, 86189, 86341, 86575, 86914, 86981, 87359, 87364, 100788, 101036, 101077, 101612, 101952, 102664, 103147, 103238, 103265, 103270, 103281, 103283, 103380, 103525, 103526, 103562, 103564, 103781, 103891, 104075, 104076, 104077, 104149, 104464, 104497, 104670, 104950, 104952, 104953, 104954, 104955, 104956, 104957, 104958, 104959, 105073, 105139, 105140, 105304, 105489, 105598, 105670, 105674, 105779, 105953, 105960, 203880, 215045, 215140, 500038, 504493, 504655, 504666, 504674, 504733, 504742, 504747, 504776, 504779, 505064, 505077, 505111, 505111, 505252, 505271, 505281, 505363, 505421, 505486, 505530, 505538, 505650, 505809, 505858, 505860, 505861, 505876, 505968, 506026, 506049, 506069, 506119, 506169, 506469, 506509, 506538, 506539, 506540, 506541, 506564, 506616, 506621, 506637, 506778, 519115, 519118, 519136, 519195, 519196, 519197, 519198, 519211, 519534, 519536, 519537, 519548, 519680, 519730, 519733, 519738, 519812, 519894, 519895, 519899, 519901, 520236, 520275, 520309, 520319, 520430, 520431, 520491, 520523, 520524, 520526, 520582, 520598, 520630, 520631, 520632, 520660, 520680, 520681, 520688, 520701, 520755, 520779, 520783, 520793, 520807, 520814, 520948, 520956, 520964, 520977, 521001, 521154, 521221, 521222, 521223, 521311, 521312, 521314, 521315, 521318, 521325, 521463, 521512, 521537, 521545, 521548, 521589, 521650, 521659, 521675, 521711, 521763, 521820, 521853, 521854, 521890, 521892, 522065, 522118, 522119, 522136, 522138, 522155, 522162, 522177, 522243, 522245, 522253, 522293, 522397, 522440, 522446, 522456, 522458, 530361, 530368, 530391, 530392, 530393, 530396, 530421, 530459, 530460, 530463, 530464, 530584, 530653, 530654, 530656, 530660, 530662, 530663, 530664, 530667, 530668, 530669, 530715, 530783, 531649, 531651, 531728, 531752, 531753, 531758, 531760, 531762, 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Why it was recalled

Monitor ceiling carriage may separate from the monitor ceiling suspension.

Root cause (FDA determination)

Other

Action the firm took

On 07/02/08, the firm sent a "Urgent - Device Correction" letter to all their consignees. The letter describes a product as X-Ray system with Monitor Ceiling Suspension and motorized height movement. The consignees are informed that the fixation bolts supporting the monitor ceiling carriage may come loose creating a situation which may allow the monitor ceiling carriage to separate from motorized height Monitor Ceiling Suspension and that would cause serious injury to patient and user. The firm has issued a mandatory Field Correction Action to correct the problem and the firm's technicians will inspect all ceiling suspension actuators for loose screws. If loose screws are found the actuator will be replaced. Consignees should call Philips Call Center at 800-722-9377 #5, #4, #1, and Reference FCO72200126.

Recalling firm

Firm: Philips Medical Systems North America Co. Phillips
Address: 22100 Bothell Everett Hwy, Bothell, Washington 98021-8431

Distribution

Distribution pattern: United States and Canada.

Timeline

Recall initiated: 2008-06-26
Posted by FDA: 2010-08-11
Terminated: 2010-12-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #72469. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.