Philips DigitalDiagnost Systems 의 리콜

Recall

62884

Class 2

Z-2384-2012

2012-08-14

2012-09-14

Terminated

United States

2017-01-17

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111935

Creepage distance between the two primary phases in the geo transformer is 4.5 mm.Does not meet (iec) international standard of 5.5 mm.

Philips Healthcare Imaging issued an Urgent - Field Safety Notice dated August 8, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. The unit will be exchanged with a new unit that complies with the IEC requirements. Please reference Field Change Order (FCO) 71200081 when contacting I your local Philips representative. 1-800-722-9377. Customer were instructed to review the information contained in the letter with all members of their staff who need to be aware of the contents of the letter and to maintain a copy of the letter with the equipment instruction for Use. For further assistance, customers should contact their local Phillips representative: Technical Support Line 1-800-722-9377. For questions regarding this recall call 978-687-1501.