September 20, 2006
Recipient: Terumo Cardiovascular Systems.Product:Advanced Perfusion System (APS-1) Date:8/31/06 Failure to file a report of corrections or removals as required by Subpart B of 21 CFR 806. For example, your firm failed to promptly report to the FDA, as required by 21 CFR.806.10, the field correction action number NFC 813720, an action performed by your firm...
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Company: Philips Medical Systems Date of Enforcement Report:9/20/2006 Class:ll PRODUCT IntelliVue MultiMeasurement Server (MMS)/Multimeasurement Server, physiological patient monitoring system. Model: M3001A, Recall # Z-1487-06 REASON Patient monitor may display inaccurate reading when the Disposable Sp02 Sensor is not attached . CODE M3001A options A01, A01C06, A01C12, and A01C18 with serial number prefix DE512 and MMS...
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