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FDA identifies Abbott Proclaim recall as Class I

Abbott is recalling its Proclaim and Infinity IPGs due to complaints from patients who are unable to exit MRI mode, noted the FDA, which identifies July 18 as the date the recall was initiated by the firm. “The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death,” the recall notice posted today to the FDA site stated.

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