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Showing 2721–2740 of 22584 results

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Aespire 7900 (Datex-Ohmeda) – Gas Outlet Risk (2024)

Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.

FDAJul 12, 2024Nationwide• Datex-Ohmeda, Inc.

Aespire View (Datex-Ohmeda) – Gas Outlet Risk (2024)

Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.

FDAJul 12, 2024Nationwide• Datex-Ohmeda, Inc.

Avance (Datex-Ohmeda) – Gas Outlet Risk (2024)

Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.

Moderate

FDAJul 12, 2024Nationwide• Datex-Ohmeda, Inc.

Aisys CS2 (Datex-Ohmeda) – Gas Outlet Risk (2024)

Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.

FDAJul 12, 2024Nationwide• Datex-Ohmeda, Inc.

Aisys CS2 (Datex-Ohmeda) – Gas Outlet Risk (2024)

Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.

FDAJul 12, 2024Nationwide• Datex-Ohmeda, Inc.

Contour Gold Eyelid Weight (Meddev) – Mislabeling (2024)

Due to mislabeling of products

FDAJul 12, 2024Nationwide• Meddev Corp

RMU-2000 Chest Compression Device (Defibtech) – Motor Failure (2024)

Problem in the device's motor may cause the device to stop compressions. This may lead to a delay in therapy if the device fails to operate, and could lead to patient injury or death.

FDAJul 12, 2024CT, FL, NJ +2 more• Defibtech, LLC

2090 Programmers (Medtronic) – Cursor Motion Issue (2024)

Medtronic CareLink 2090 programmers with serial number prefixes PKK0 and PKK1 have the potential for autonomous cursor motion when Finger Touchscreen capability is enabled by software version 3.2 or higher.

FDAJul 11, 2024Nationwide• Medtronic Inc.

Guidewire (Bard Peripheral Vascular) – Misassembly Risk (2024)

Due to guidewires being manufactured incorrectly with the guidewires being mis-assembled within the hoop such that the proximal (stiff) end of the guidewire is located at the distal end of the hoop. Injury could occur if the user attempts to insert the proximal end into the patient.

FDAJul 10, 2024Nationwide• Bard Peripheral Vascular Inc 1625 W 3rd St Bldg 1 850 W. Rio Salado Prkwy. Tempe AZ 85281-2438

DxC 500 AU Analyzer (Beckman Coulter) – Software Rack Limitation (2024)

Due to a software issues, after the instrument processes 250 racks cumulatively, any subsequent racks with samples requiring rerun/reflex will be held in the Sample Handler's Buffer area and and error code "9000" will be reported. This issue may cause a delay of results.

FDAJul 10, 2024Nationwide• Beckman Coulter Mishima K.K. 454-32 Higashino; Nagaizumi-Cho Sunto-Gun Japan

DxI 9000 Analyzer (Beckman Coulter) – Pneumatics Tubing Leak (2024)

Beckman Coulter is recalling the DxI 9000 Access Immunoassay Analyzer due to undersized Pneumatics Tubing in the reagent storage module causing air leaks, compressor failures or sample processing errors. Four complaints were filed for this event that led to Beckman Coulter finding undersized tubing in stock and initiated corrective actions. Use of the affected device may result in errors leading to delay of results.

FDAJul 10, 2024Nationwide• Beckman Coulter, Inc.

VITROS XT ALB-TP Slides (Ortho-Clinical) – Dust Shedding (2024)

The reason for this recall is QuidelOrtho has determined that during normal use the VITROS XT ALB-TP Slides may shed dust and debris as they travel through the MicroSlide Subsystem of the VITROS XT 3400 or VITROS XT 7600 analyzer. This dust and debris may then settle onto VITROS Na+ (Sodium) Slides as they are processed through the same MicroSlide Subsystem, potentially resulting in an increase in non-reproducible, positively, or negatively biased Na+ results. The level of bias will depend on where the dust and debris settle on the Na+ MicroSlide and may impact Na+ measurements to varying degrees inside and outside of the measuring range depending on the amount of contamination. All of which could vary from no/low bias with no patient harm, to extreme bias (falsely elevated or reduced results) potentially resulting in incorrect diagnosis; treatment; and/or a serious patient health hazard (for example, hypernatremia or hyponatremia). This issue may also potentially generate error codes preventing the analyzer from processing the MicroSlide Assays and cause delay of the patient results. All current and expired VITROS XT Chemistry Products ALB-TP slides are affected by this issue.

FDAJul 10, 2024Nationwide• Ortho-Clinical Diagnostics, Inc.

Proton Therapy System (IBA) – Positioning System Issue (2024)

Temporary deactivation of collision detection for Forte Robotic Patient Positioning System occasionally experiences issues

FDAJul 10, 2024IL, LA, MI +6 more• Ion Beam Applications S.A. Chemin Du Cyclotron 3 Ottignies-Louvain-La-Neuve Belgium

Aurora 7 Lighthead (DKK Dai-Ichi) – Weld Frame Crack (2024)

The weld on the light head frame can crack which could lead to problems such as the light head frame sagging, the plastic front face housing cracking, or the light head detaching.

FDAJul 9, 2024Nationwide• DKK Dai-Ichi Shomei Co., Ltd. 1 Chome 32-26 Sakashita Itabashi Japan

Pyxis QFill Station (CareFusion) – Label Printing Issue (2024)

Due to software issue, there is a potential when a restock label is printed for a medication stored in a non-CUBIE location, that the incorrect bin for the medication is printed on the label.

FDAJul 9, 2024Nationwide• CareFusion 303, Inc.

McGrath Mac Laryngoscope (Covidien) – Battery Risk (2024)

Battery management system within Laryngoscope devices may deplete below the deign threshold which may result in thermal event followed by risk of explosion.

FDAJul 9, 2024Nationwide• Covidien

TruDi NAV Suction (Integra LifeSciences) – Calibration Error (2024)

Specific lots of TruDi NAV Suction Instruments 0 Degrees were incorrectly calibrated which when used with the TruDi Navigation System, may result in a discrepancy between the actual tip location and the visualized location displayed on the system.

FDAJul 9, 2024AL, AZ, CA +32 more• Integra LifeSciences Corp.

Kiestra Urine Culture App (Becton Dickinson) – Inaccurate Counting (2024)

There is a potential risk that the image colony count does not adequately reflect the actual plate colony count and may lead to inaccurate counts that would impact patient diagnosis and subsequent care.

FDAJul 9, 2024CO, CT, IL +14 more• Becton Dickinson & Co.

DLP Venous Cannulae (Medtronic) – Incorrect Product Placement (2024)

During manufacturing, DLP Single Stage Venous Cannulae - straight tip (Model 66118) was incorrectly placed into a product labeled as DLP Single Stage Venous Cannulae - right angle metal tip (Model 67312).

FDAJul 9, 2024Nationwide• Medtronic Perfusion Systems

Aurora 4 Lighthead (DKK Dai-Ichi) – Weld Frame Crack (2024)

The weld on the light head frame can crack which could lead to problems such as the light head frame sagging, the plastic front face housing cracking, or the light head detaching.

FDAJul 9, 2024Nationwide• DKK Dai-Ichi Shomei Co., Ltd. 1 Chome 32-26 Sakashita Itabashi Japan

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