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All product recalls associated with Philips Medical Systems North America Co. Phillips.
Total Recalls
110
Past Year
0
Class I (Serious)
0
Most Recent
Jul 2009
Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.
Review by firm of Philips EasyVision MM workstations found that to assure compliance with 21 CFR 900.12(c)(5) corrected software was needed so that all sites are in compliance.
Patient and image data can be exchanged when a patient is selected in the patient list and the examination tab is pressed with background query running at the same time. There is a risk that the data may then be linked to the incorrect patient, which may adversely affect diagnosis and treatment.
System fails to meet requirements when it is used at kV levels greater than 115 kV at certain frame rates and in certain acquisition modes, as grid switch leakage may occur.