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Showing 7621–7640 of 11714 results

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MectaLIF Anterior Anti-backout Cover (Medacta) – Screw Breakage Risk (2023)

There is a potential for breakage of the small screw used to affix the anti-backout plate.

FDAMar 8, 2023AZ, GA, ID +2 more• Medacta Usa Inc

Samsung GM85 X-ray System (NeuroLogica) – Arm Latch Safety (2023)

Issue related to the operation of the arm latch within the column that supports the arm, potential bodily harm due to a fall of the arm

FDAMar 8, 2023Nationwide• NeuroLogica Corporation

Mektovi 15mg Tablets (Pfizer) – Incorrect Expiration (2023)

Labeling: Incorrect or Missing Lot and/or Exp Date: The carton and bottle labels state an expiry date of March 2026; the correct expiration date is February 2025.

Class IIILow

FDAMar 8, 2023Nationwide• Pfizer Inc.

REX Pressure Therapy System (Compass Health) – User Manual Error (2023)

Error in the Introduction section of the user manual that indicates the device may be used for the prevention of deep vein thrombosis (DVT). Marketed without a 510k for this indication

FDAMar 7, 2023Nationwide• Compass Health Brands (Corporate Office)

VASOVIEW HEMOPRO Vessel Harvesting System (Maquet) – Sterilization Spec (2023)

Some batches of product were not sterilized to their minimum sterilization specification.

FDAMar 6, 2023Nationwide• Maquet Cardiovascular, LLC

VASOVIEW HEMOPRO 2 Vessel Harvesting System (Maquet) – Sterilization Spec (2023)

Some batches of product were not sterilized to their minimum sterilization specification.

FDAMar 6, 2023Nationwide• Maquet Cardiovascular, LLC

EarlyVue VS30 Vitals Monitor (Philips) – CO2 Measurement Risk (2023)

EarlyVue VS30 Vital Signs Monitor and EarlyVue VS30 Vitals monitor Missing Calibration Alarm, a risk of an inaccurate CO2 measurement which may lead to a failure to recognize a change in patient condition.

FDAMar 6, 2023Nationwide• Philips North America Llc

EarlyVue VS30 Vitals Monitor (Philips) – CO2 Measurement Risk (2023)

EarlyVue VS30 Vital Signs Monitor and EarlyVue VS30 Vitals monitor Missing Calibration Alarm, a risk of an inaccurate CO2 measurement which may lead to a failure to recognize a change in patient condition.

FDAMar 6, 2023Nationwide• Philips North America Llc

VASOVIEW HEMOPRO OUS Vessel Harvesting System (Maquet) – Sterilization Spec (2023)

Some batches of product were not sterilized to their minimum sterilization specification.

FDAMar 6, 2023Nationwide• Maquet Cardiovascular, LLC

HydroPICC Catheter Kit (Access Vascular) – Expiration Date Mismatch (2023)

The catheter packaged with specific lots of the HydroPICC Kits and HydroMID Kits have a shorter expiration date than what is listed on the outer kit package.

FDAMar 3, 2023FL, TN, TX• Access Vascular, Inc

ProxiDiagnost N90 R.1.0 (Philips) – Compliance Issue (2023)

Philips has identified a compliance issue where ProxiDiagnost N90 R.1.0, CombiDiagnost R90 R.1.0 and CombiDiagnost R90 R1.1 systems are missing a certification label required by the Food and Drug Administration (FDA).

FDAMar 3, 2023Nationwide• Philips North America

CombiDiagnost R90 R.1.0 (Philips) – Compliance Issue (2023)

Philips has identified a compliance issue where ProxiDiagnost N90 R.1.0, CombiDiagnost R90 R.1.0 and CombiDiagnost R90 R1.1 systems are missing a certification label required by the Food and Drug Administration (FDA).

FDAMar 3, 2023Nationwide• Philips North America

CombiDiagnost R90 R1.1 (Philips) – Compliance Issue (2023)

Philips has identified a compliance issue where ProxiDiagnost N90 R.1.0, CombiDiagnost R90 R.1.0 and CombiDiagnost R90 R1.1 systems are missing a certification label required by the Food and Drug Administration (FDA).

FDAMar 3, 2023Nationwide• Philips North America

Centurion CirClamp (Medline) – Incorrect Size (2023)

The CirClamp subassembly found in the kit was the incorrect size.

FDAMar 2, 2023Nationwide• MEDLINE INDUSTRIES, LP Northfield

NanoKnife Procedure Pack (Angiodynamics) – RFID Recognition (2023)

Not programmed in accordance with specification. The programming affects the RFID function and does not allow the NanoKnife probes to be recognized by the NanoKnife generator resulting in a delay in procedure

FDAMar 2, 2023Nationwide• Angiodynamics, Inc.

SafeLight Fiber Optic Cable (Stryker) – Light Output Issue (2023)

Fiber optic cables assembled with not enough epoxy on the proximal end, creating light output issues, which could cause a clinical delay or procedure being converted to open.

FDAMar 2, 2023Nationwide• Stryker Corporation

Cirq Arm System 2.0 (Brainlab) – Mechanical Instability (2023)

Risk of mechanical instability due to potential manufacturing error of the device

FDAMar 2, 2023TX• Brainlab AG Olof-palme-str. 9 Munich Germany

United Imaging PET System (Shanghai United Imaging) – Scatter Correction Failure (2023)

Due to a software issue where the process of patient scanning, the scatter correction may occasionally fail with will potentially cause a failure of the PET image reconstruction and generation of PET images.

FDAMar 1, 2023Nationwide• Shanghai United Imaging Healthcare Co., Ltd. No. 2258 Chengbei Rd, Jiading Ind. Shanghai China

Titan Touch NB Prosthesis (Coloplast) – Pump Failure Risk (2023)

A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thickness, based on the number of interactions with the pump to inflate and deflate the penile prosthesis.

FDAMar 1, 2023Nationwide• Coloplast Manufacturing US, LLC

Titan Touch NB Prosthesis (Coloplast) – Pump Failure Risk (2023)

A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thickness, based on the number of interactions with the pump to inflate and deflate the penile prosthesis.

FDAMar 1, 2023Nationwide• Coloplast Manufacturing US, LLC

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