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Anivia SG1000 Pump Console

APMTD, Inc. · Model SG1000-LSM-001 · UDI-DI 00850000067134

DTW Prescription
10
510(k) clearances
153
Adverse events
15
Recalls
6
Facilities

Description

Level Sensor Module

Recalls

DateFirmReason
2007-01-12Terumo Cardiovascular Systems CorpThe hand crank may crack in the bearing/shaft area due to a manufacturing defect. (Note: Some of the hand cranks subject to this recall were shipped as replacements for hand cran
2007-01-12Terumo Cardiovascular Systems CorpThe hand crank may crack in the bearing/shaft area due to a manufacturing defect. (Note: Some of the hand cranks subject to this recall were shipped as replacements for hand cran
2007-01-12Terumo Cardiovascular Systems CorpThe hand crank may crack in the bearing/shaft area due to a manufacturing defect. (Note: Some of the hand cranks subject to this recall were shipped as replacements for hand cran
2007-01-12Terumo Cardiovascular Systems CorpThe hand crank may crack in the bearing/shaft area due to a manufacturing defect. (Note: Some of the hand cranks subject to this recall were shipped as replacements for hand cran
2007-01-12Terumo Cardiovascular Systems CorpThe hand crank may crack in the bearing/shaft area due to a manufacturing defect. (Note: Some of the hand cranks subject to this recall were shipped as replacements for hand cran
2006-09-14Terumo Cardiovascular Systems CorpThe hand crank handle may separate and detach from the unit during use.
2006-09-14Terumo Cardiovascular Systems CorpThe hand crank handle may separate and detach from the unit during use.
2006-09-14Terumo Cardiovascular Systems CorpThe hand crank handle may separate and detach from the unit during use.
2006-09-14Terumo Cardiovascular Systems CorpThe hand crank handle may separate and detach from the unit during use.
2006-09-14Terumo Cardiovascular Systems CorpThe hand crank handle may separate and detach from the unit during use.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.