Simplifying Global Compliance
FDAnews Device Daily Bulletin
China Department of Health Issues Safety Notice for X-Ray Device
Nov. 1, 2011
The Chinese Department of Health has issued a field correction notice
for Boston Scientific’s SCS remote control, charger, external trial stimulator, trial patient belt and charger belt. While the devices do not need to be returned to Boston Scientific following an earlier recall for incorrect literature on device usage, the notice asks customers to submit a reply verification tracking form.
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