483
IPG Medical CorporationIPG Medical Corporation – FDA 483, Nov 4, 2025
Record Details
IPG Medical Corporation in Marlborough, MA, was inspected by the FDA from October 29 to November 4, 2025. The inspection revealed a significant safety concern regarding their Class 4 Thuvera Laser System, which lacked a required removable key to prevent unauthorized operation. This indicates a potential risk related to laser product safety controls.
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ID · 9b002f70-3484-47ef-a81b-4711ceeafb87
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