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U.S. Department of Health and Human Services

Class 2 Device Recall Diagnost 56/66/76/76 Plus

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 Class 2 Recall
Diagnost 56/66/76/76 Plus
see related information
Date Posted September 13, 2010
Recall Status1 Terminated on September 13, 2010
Recall Number Z-2404-2010
Recall Event ID 46217
Premarket Notification
510(K) Number
K924593 
Product Classification Device, Spot-Film - Product Code IXL
Product Diagnost 56/66/76/76 Plus, DSI is a Spot-Film and has a Digital Imaging Spot. Intended use is for the following applications: as a multifunctional/universal system, general R/F, Fluoroscopy, Radiology, and Angiography can be performed along with pediatric examinations and more specialized interventional applications.
Code Information Devices are identified as Site Numbers: 73421, 46653, 59224, 62325, 13479, 46954, 25563, 61812, 34800, 13612, 13624, 68220, 35590, 68219, 17576, 59474, 35420, 62630, 44890, 41239, 13691, 59011, 47149, 44888, 6709, 6824, X1007, and X1775.
Recalling Firm/
Manufacturer
Philips Medical Systems North America Co. Phillips
22100 Bothell Everett Hwy
Bothell, Washington 98021-8431
For Additional Information Contact Philips Call Center
800-722-9377
Manufacturer Reason
for Recall
Potential for the tower (holding the serial changer and/or image intensifier) to slide unexpectedly and potentially injure a patient or user in its path.
FDA Determined
Cause 2
OTHER/UNDETERMINED: Pending
Action On 1/4/08, the firm issued the URGENT PRODUCT CORRECTION letter dated 1/3/08 to their consignees via certified mail, return receipt requested. The letter informs consignees the issue of the safety switch and counter weight steel band on the Diagnost 55/66/76Plus, Easy Diagnost, and Easy Diagnost Eleva X-ray systems. However, the Easy Diagnost Eleva X-ray system was distributed and applied only to foreign consignees outside US. If the consignees hear the primary steel band clicking/rattling noise while tilting the table to 90 degrees table or positioning the serial changer, the consignees are instructed to tilt the table base towards the 0 degree tilting position and do not use the tilting drive movement until the mandatory action by a Philips service representative has been performed. The Field Change Order (FCO) would be implemented on 01/23/08 and expected to be completed by July 2008. The firm's representatives will visit sites and will inspect all systems where the switch has been replaced or adjusted for proper operation of the safety sensor and switch. Two steel bands will be inspected and replaced if any abnormity is noted. In the mean time, consignees should contact Philips Call Center at 800-722-9377, #5, #2 and reference the FCO 70600029 with any questions.
Quantity in Commerce 28 units
Distribution Nationwide Distribution
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = IXL and Original Applicant = PHILIPS MEDICAL SYSTEMS, INC.
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