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Risk Analysis Deficiencies The FDA criticized Zoll's risk assessment procedures, stating the company "failed to perform a complete complaint history search while performing a health risk assessment." For the 731 Ventilators MRI compatibility issue, "the risk was calculated only by using the adverse events (24 malfunction reports) and complaints (27 complaints)," but FDA investigators "found there were 50 complaints, not 27, received from 2016 to 2024." Supplier management issues Zoll failed to properly categorize critical suppliers
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