This article has been updated with comments from Dräger Medical.

The FDA has issued a warning letter to Dräger Medical following an inspection of its Andover, Mass., facility in August and September 2019.

The agency faulted the patient-monitoring company for failing to file for 510(k) clearance of its Infinity acute care system (IACS) M540 although it made “significant modifications” to the device that could affect its safety and effectiveness.

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