Class 2 Device Recall EasyDiagnost DSI

• Date Initiated by Firm: January 04, 2008
• Date Posted: September 13, 2010
• Recall Status: Terminated on September 13, 2010
• Recall Number: Z-2406-2010
• Recall Event ID: 46217
• 510(K)Number: K023440 K920793
• Product Classification: Radiographic Tilting Table - Product Code IXR
• Product: Easy Diagnost DSI is a Easy Diagnost Digital Spot Imaging system. It has a capability to create digital images from an analog system.; ; 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: 62663, 76379, 38988, 38689, 41468, 82571,102466, 103158, and 104104.
• Recalling Firm/ Manufacturer: Philips Medical Systems North America Co. Phillips; 22100 Bothell Everett Hwy; Bothell WA 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: Other
• 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: 9 units
• Distribution: Nationwide Distribution
• 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.

• 510(K) Database: 510(K)s with Product Code = IXR and Original Applicant = PHILIPS MEDICAL SYSTEMS; 510(K)s with Product Code = IXR and Original Applicant = PHILIPS MEDICAL SYSTEMS, INC.