—#67009

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.

FDA product code: IXL — Device, Spot-Film
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K924593
Affected lot / code info: 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.

Why it was recalled

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.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

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

Distribution

Distribution pattern: Nationwide Distribution

Timeline

Recall initiated: 2008-01-04
Posted by FDA: 2010-09-13
Terminated: 2010-09-13
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #67009. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.