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Showing 7261–7280 of 8389 results

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Implant Direct Sybron Manufacturing LLC: ImplantDirect, REF 834713, Legacy 2 Implant 4.7mmD x 13mm...

Packaged dental implant contains a different size then the size declared on the labeling.

FDASep 23, 2021Nationwide• Implant Direct Sybron Manufacturing LLC

Medtronic Neuromodulation: Clinician Programmer Application (CPA) model A610 Clinici...

A software anomaly may occur with the clinician programmer application.

FDASep 23, 2021Nationwide• Medtronic Neuromodulation

bioMerieux, Inc.: VIDAS Clostridium Difficile GDH, REF 30125-01

bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test.

FDASep 22, 2021Nationwide• bioMerieux, Inc.

bioMerieux, Inc.: VIDAS Lyme IgM II (LYM), REF 416436

bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test.

FDASep 22, 2021Nationwide• bioMerieux, Inc.

bioMerieux, Inc.: VIDAS RUB IgG (RBG), REF 30226

bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test.

FDASep 22, 2021Nationwide• bioMerieux, Inc.

bioMerieux, Inc.: VIDAS SARS-COV-2 IgG, Ref 423834-01

bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test.

FDASep 22, 2021Nationwide• bioMerieux, Inc.

Intuitive Surgical, Inc.: da Vinci SP Surgical systems with the following Model Nam...

Issue was identified during internal engineering evaluation. Use of the system with the affected software version may experience either an inability to deliver energy or an inadvertent delivery of energy. Use may require surgeon to resolve an injury or need moderate intraoperative intervention. Also, use may potentially cause user frustration or a minor delay to troubleshoot.

FDASep 22, 2021Nationwide• Intuitive Surgical, Inc.

bioMerieux, Inc.: VIDAS Clostridium Difficile Toxin A&B, CDAB,REF 30118-01

bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test.

FDASep 22, 2021Nationwide• bioMerieux, Inc.

RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden: RayStation/RayPlan versions 4 - 11A, including service pa...

An issue where the combined density in a dose grid voxel partially covered by the External ROI and also partially covered by an ROI of type Bolus, Support or Fixation may be unexpected.The density in the voxel can be both under- and overestimated

FDASep 22, 2021Nationwide• RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden

bioMerieux, Inc.: VIDAS Mumps IgG (MPG), REF 30218

bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test.

FDASep 22, 2021Nationwide• bioMerieux, Inc.

bioMerieux, Inc.: VIDAS TOXO IgG Avidity (TXGA), REF 30222-01

bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test.

FDASep 22, 2021Nationwide• bioMerieux, Inc.

bioMerieux, Inc.: VIDAS FSH, REF 30407-01

bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test.

FDASep 22, 2021Nationwide• bioMerieux, Inc.

MEDTECH SAS 900 Rue Du Mas De Verchant Montpellier France: ROSA One 3.1 Brain application The device is intended fo...

The firm has become aware of a software anomaly affecting ROSA One 3.1 Brain application which led to the inaccurate placement of an electrode during surgery. The firm has received 3 global complaints related to the issue. An incorrect trajectory could result in serious injury or death if undetected during surgery.

FDASep 22, 2021Nationwide• MEDTECH SAS 900 Rue Du Mas De Verchant Montpellier France

bioMerieux, Inc.: VIDAS Measles IgG (MSG), REF 30219

bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test.

FDASep 22, 2021Nationwide• bioMerieux, Inc.

Philips Healthcare: DigitalDiagnost C90

The Aleva monitor requires certain labels to be applied, some of which are required by FDA Electronic Product Radiation Control performance standards. This includes the Radiation Warning Label [21CFR 1020.30 (j)] and the X-ray control certification statement [21 CFR 1010.2]. Philips has determined that some systems at customer locations did not have these labels applied.

FDASep 22, 2021Nationwide• Philips Healthcare

bioMerieux, Inc.: VIDAS DEX@, Dimer Exclusion II, REF 30455-01

bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test.

FDASep 22, 2021Nationwide• bioMerieux, Inc.

bioMerieux, Inc.: VIDAS B.R.A.H.M.S. PROCALCITONIN PCT, REF 30450-01

bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test.

FDASep 22, 2021Nationwide• bioMerieux, Inc.

bioMerieux, Inc.: VIDAS LH, REF 30406-01

bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test.

FDASep 22, 2021Nationwide• bioMerieux, Inc.

Philips Healthcare: ProxiDiagnost N90 is multi-functional general R/F systems.

The Aleva monitor requires certain labels to be applied, some of which are required by FDA Electronic Product Radiation Control performance standards. This includes the Radiation Warning Label [21CFR 1020.30 (j)] and the X-ray control certification statement [21 CFR 1010.2]. Philips has determined that some systems at customer locations did not have these labels applied.

FDASep 22, 2021Nationwide• Philips Healthcare

bioMerieux, Inc.: VIDAS PRG Progesterone, REF 30409-01

bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test.

FDASep 22, 2021Nationwide• bioMerieux, Inc.

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