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Showing 7021–7040 of 8393 results

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PCA 4000 Curing Units (Envisiontec) – Resin Curing Problem (2022)

The PCA 4000 may not fully cure EnvisionTEC dental resins to desired product specifications.

FDAJan 20, 2022Nationwide• Envisiontec US Llc

Lumbar Puncture Tray Pediatric (Bard) – Manometer Failure (2022)

Due to lumbar puncture tray manometer failure mode of leaking and mating issues.

FDAJan 20, 2022Nationwide• Bard Peripheral Vascular Inc

YelloPort Elite Trocar (Surgical Innovations) – Sterility Labeling (2022)

Laparoscopic devices have a sterile symbol included on labels but devices are non-sterile.

FDAJan 20, 2022MA• Surgical Innovations Ltd 6 Clayton Wood Bank Lds Leeds United Kingdom

Lumbar Puncture Tray Adult (Bard) – Manometer Failure (2022)

Due to lumbar puncture tray manometer failure mode of leaking and mating issues.

FDAJan 20, 2022Nationwide• Bard Peripheral Vascular Inc

Sight OLO Blood Analysis Device (Sight Diagnostics) – Reference Range Issue (2022)

In instances where custom reference ranges were configured on the device post installation, a possibility to inadvertently apply changes to reference range values was found on software versions 2.59.3 and all earlier versions, which can potentially lead to displaying and printing incorrectly-configured reference range values

FDAJan 20, 2022Nationwide• SIGHT DIAGNOSTICS LTD 23, Derekh Menakhem Begin Tel Aviv-Yafo Israel

YelloPort Plus Cannula (Surgical Innovations) – Sterility Labeling (2022)

Laparoscopic devices have a sterile symbol included on labels but devices are non-sterile.

FDAJan 20, 2022MA• Surgical Innovations Ltd 6 Clayton Wood Bank Lds Leeds United Kingdom

Safe-T Plus Lumbar Puncture Tray (Bard) – Manometer Failure (2022)

Due to lumbar puncture tray manometer failure mode of leaking and mating issues.

FDAJan 20, 2022Nationwide• Bard Peripheral Vascular Inc

Safe-T Plus Lumbar Puncture Tray (Bard) – Manometer Failure (2022)

Due to lumbar puncture tray manometer failure mode of leaking and mating issues.

FDAJan 20, 2022Nationwide• Bard Peripheral Vascular Inc

QMS Tacrolimus Calibrator (Microgenics) – Value Recovery Issue (2022)

Due to QMS Tacrolimus Calibrator recovering between 82 to 94% of their target values, resulting in over-quantitation in tacrolimus patient result values when used with the QMS Tacrolimus Immunoassay.

FDAJan 20, 2022AL, AZ, CA +18 more• Microgenics Corporation

Adult Lumbar Puncture Drug Free Tray (Bard) – Manometer Failure (2022)

Due to lumbar puncture tray manometer failure mode of leaking and mating issues.

FDAJan 20, 2022Nationwide• Bard Peripheral Vascular Inc

BenchMark Ultra Instruments (Ventana) – Fluid Leak Risk (2022)

Potential for Fluid Leak inside a staining system that could cause an electrical short circuit of the General Purpose Input/ Output Board's J1 Connector that could result in smoke and fire.

FDAJan 20, 2022AL, AK, AZ +49 more• Ventana Medical Systems Inc

SyncVision Systems (Volcano) – Measurement Calculation Error (2022)

If FFR measurement(s) are made prior to an iFR/FFR co-registration/pullback in the same procedural session, this could result in incorrect iFR/FFR Co-Registration results to be displayed, that may cause users to mistakenly use incorrect measurements, leading to inappropriate patient treatment. Image acquisition and processing system operators manual to be updated to include workflow alternatives.

FDAJan 19, 2022AL, AK, AZ +43 more• Volcano Corporation

ACUSON Juniper Ultrasound (Siemens) – Clip Store Malfunction (2022)

The clip store function in the ultrasound imaging system does not work when the system has a disk full error. This could cause a delay in treatment if the ultrasound system is unable to save clips as study documentation during a high risk procedure, such as a stress echo exam.

FDAJan 19, 2022Nationwide• Siemens Medical Solutions USA, Inc.

LINQ II Cardiac Monitor (Medtronic) – Moisture Ingress Risk (2022)

Devices may lose functionality due to susceptibility to moisture ingress.

FDAJan 18, 2022Nationwide• Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Opaque Herrick Lacrimal Plugs (Lacrimedics) – Pouch Seal Issue (2022)

The sterile pouch seal may contain channels that could affect the seal integrity and potentially compromise sterility.

FDAJan 17, 2022Nationwide• Lacrimedics Inc

Collagen Plugs (Lacrimedics) – Pouch Seal Issue (2022)

The sterile pouch seal may contain channels that could affect the seal integrity and potentially compromise sterility.

FDAJan 17, 2022Nationwide• Lacrimedics Inc

Biolox Delta Ceramic Femoral Head (Howmedica) – Size Labeling Error (2022)

Potential product mix where the size and/or offset of the Biolox delta Ceramic V40 Femoral Head inside the package does not match the package labeling

FDAJan 14, 2022Nationwide• Howmedica Osteonics Corp.

CIRRUS HD-OCT Angioplexs (Carl Zeiss) – Scan Clearance Issue (2022)

Optic nerve head angiography scan to be turned off due to its distribution without pre-market clearance.

FDAJan 14, 2022Nationwide• Carl Zeiss Meditec, Inc.

1688 Camera Control Unit (Stryker) – Image Orientation Defect (2022)

A software defect in the camera control unit (CCU) will cause the image on the monitor to flip upside-down into an incorrect orientation. The potential of harms are conversion to open procedure, additional medical intervention, or a revision surgery.

FDAJan 14, 2022Nationwide• Stryker Corporation

Everest MI XT Inner Dilator (Unknown) – Fitting Problem (2022)

Stryker received two (2) complaints for units from specific lots of Inner and Outer Dilators not fitting together properly during a surgical procedure. Some dilators from these lots and from other lots were subsequently determined to be affected by a manufacturing nonconformance.

FDAJan 13, 2022Nationwide

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