Class 2 Device Recall Motorized Height Ceiling Suspensions (MCS) for CV Xray systems

• Date Initiated by Firm: June 26, 2008
• Date Posted: August 11, 2010
• Recall Status: Terminated on December 02, 2010
• Recall Number: Z-2210-2010
• Recall Event ID: 48992
• Product Classification: Motorized Height Ceiling Suspension - Product Code IZI
• 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.
• Code Information: 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, 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• Recalling Firm/ Manufacturer: Philips Medical Systems North America Co. Phillips; 22100 Bothell Everett Hwy; Bothell WA 98021-8431
• For Additional Information Contact: Bob Pettis; 425-487-7469
• Manufacturer Reason for Recall: Monitor ceiling carriage may separate from the monitor ceiling suspension.
• FDA Determined Cause: Other
• Action: 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.
• Quantity in Commerce: 1111 units
• Distribution: United States and Canada.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.