Device Recall EasyDiagnost DSI 의 리콜

Recall

46217

Class 2

Z-2406-2010

2008-01-04

2010-09-13

Terminated

United States

2010-09-13

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=67011

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.

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.