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U.S. Department of Health and Human Services

Medical Device Recalls

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Product Description
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MISAGO RX Self Expanding Peripheral Stem 2 Nov-29-2016 Terumo Medical Corp
MSS CASSETTE GLU/LAC/UREA (BUN) as a part of the Roche OMNI S Analyzer: cobas b 221<6>Roche OMNI S6... 2 Nov-29-2016 Roche Diagnostics Operations, Inc.
Merge Hemo software. Merge Hemo monitors, measures, and records physiologic data from a human pa... 2 Nov-28-2016 Merge Healthcare, Inc.
Merge FlexConnect software, a component of Merge LIS. Merge FlexConnect is middleware used in conju... 2 Nov-28-2016 Merge Healthcare, Inc.
ELCA Coronary Atherectomy Catheter. Models: 110-001, 110-002, 110-004, 114-009, 117-016, 117-205, 12... 2 Nov-28-2016 Spectranetics Corporation
Bridge Occlusion Balloon. Model: 590-001 Temporary vessel occlusion of the superior vena cava in ap... 2 Nov-28-2016 Spectranetics Corporation
Z6Ms transesophageal transducers used on ACUSON SC2000 ultrasound systems, Z6Ms model 10436113. R... 2 Nov-28-2016 Siemens Medical Solutions USA, Inc.
Monaco TRP System The Monaco system is used to make treatment plans for patients with prescriptions... 2 Nov-28-2016 Elekta, Inc.
Hamilton-MR1 Ventilator: Catalog# 161010 The Hamilton MR1 Ventilator is intended to provide pressu... 2 Nov-28-2016 Hamilton Medical, Inc.
Turbo Elite Atherectomy Catheter. Models: 410-152, 410-154, 414-151, 414-159, 417-152, 417-156, 420-... 2 Nov-28-2016 Spectranetics Corporation

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