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Showing 9461–9480 of 35916 results

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BD Extension Sets (Becton Dickinson) – DEHP Mislabeling (2023)

Affected infusion sets labeled as free of DEHP actually do contain di(2-ethylhexyl) phthalate (DEHP).

FDAOct 11, 2023Nationwide• Becton Dickinson & Company

BD Gravity Sets (Becton Dickinson) – DEHP Mislabeling (2023)

Affected infusion sets labeled as free of DEHP actually do contain di(2-ethylhexyl) phthalate (DEHP).

FDAOct 11, 2023Nationwide• Becton Dickinson & Company

Horizon Manual Resuscitators (SunMed Holdings) – CO2 Rebreathing Risk (2023)

A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.

High

FDAOct 11, 2023Nationwide• SunMed Holdings, LLC

VITROS 5600 System (Ortho-Clinical) – Software Issues (2023)

During planned monitoring of data post-release of Software Version 3.8.0 an increased occurrence of software issues relating to unresponsive subsystems, unresponsive user interface (sometimes referred to as a screen freeze), and/or printer disconnections was identified. The consequence of these issues would be a delay in reporting results due to the required system shutdowns to recover the system. This delay in reporting results could occur during any assay, including which the speed of the result is deemed critical or STAT and could result in a delay of treatment in a patient. Due to the release strategy of this software version, the user could not update the system but a field engineer had to manually install each affected system.

FDAOct 10, 2023Nationwide• Ortho-Clinical Diagnostics, Inc.

Xstar Kojo Safety Slit Knife (Beaver Visitec) – Incorrect Bevel (2023)

One lot of Part Number 373025, Xstar Kojo Safety Slit Knife 2.5mm 45 bevel up, incorrectly contains a bevel down blade instead of a bevel up blade.

FDAOct 10, 2023Nationwide• Beaver Visitec International, Inc.

Stay Safe Cap (Fresenius Medical) – Additional Warnings (2023)

Updating the labeling to include additional warnings and contraindications for potential side effects.

FDAOct 10, 2023Nationwide• Fresenius Medical Care Holdings, Inc.

CARDIOHELP Emergency Drive (Maquet) – Patient Exposure Risk (2023)

Product removal due to possible blocking or impairment of the CARDIOHELP Emergency Drive. This issue can lead to the patient being exposed to inappropriate low blood flow. Potential associated harms are ischemia and hypoxia.

FDAOct 10, 2023Nationwide• Maquet Medical Systems USA

VITROS XT 7600 System (Ortho-Clinical) – Software Issues (2023)

During planned monitoring of data post-release of Software Version 3.8.0 an increased occurrence of software issues relating to unresponsive subsystems, unresponsive user interface (sometimes referred to as a screen freeze), and/or printer disconnections was identified. The consequence of these issues would be a delay in reporting results due to the required system shutdowns to recover the system. This delay in reporting results could occur during any assay, including which the speed of the result is deemed critical or STAT and could result in a delay of treatment in a patient. Due to the release strategy of this software version, the user could not update the system but a field engineer had to manually install each affected system.

FDAOct 10, 2023Nationwide• Ortho-Clinical Diagnostics, Inc.

VITROS 4600 System (Ortho-Clinical) – Software Issues (2023)

During planned monitoring of data post-release of Software Version 3.8.0 an increased occurrence of software issues relating to unresponsive subsystems, unresponsive user interface (sometimes referred to as a screen freeze), and/or printer disconnections was identified. The consequence of these issues would be a delay in reporting results due to the required system shutdowns to recover the system. This delay in reporting results could occur during any assay, including which the speed of the result is deemed critical or STAT and could result in a delay of treatment in a patient. Due to the release strategy of this software version, the user could not update the system but a field engineer had to manually install each affected system.

FDAOct 10, 2023Nationwide• Ortho-Clinical Diagnostics, Inc.

AMETEK ICM-200 (AMETEK) – Software Malfunction (2023)

AMETEK ICVS (AMETEK ICVS) has submitted a Part 573 Recall Report based upon recall determinations made by Shyft Group (23V-062). The Ignition Control Module (ICM) software error may cause loss of drive power or loss of key safety functions, such as loss of head lights or windshield wipers.

NHTSAOct 10, 2023Nationwide• AMETEK

Platinum Driveline Clutch Cover (Platinum) – Potential Failure (2023)

Platinum Driveline, Inc. (Platinum Driveline) is recalling certain Platinum and Luk Mustang clutch covers, part number 361986 with 11" outer diameter plate. The clutch cover may have been manufactured with material that may break.

NHTSAOct 10, 2023Nationwide• PLATINUM DRIVELINE USA

VITROS 3600 System (Ortho-Clinical) – Software Issues (2023)

During planned monitoring of data post-release of Software Version 3.8.0 an increased occurrence of software issues relating to unresponsive subsystems, unresponsive user interface (sometimes referred to as a screen freeze), and/or printer disconnections was identified. The consequence of these issues would be a delay in reporting results due to the required system shutdowns to recover the system. This delay in reporting results could occur during any assay, including which the speed of the result is deemed critical or STAT and could result in a delay of treatment in a patient. Due to the release strategy of this software version, the user could not update the system but a field engineer had to manually install each affected system.

FDAOct 10, 2023Nationwide• Ortho-Clinical Diagnostics, Inc.

VITROS XT 3400 System (Ortho-Clinical) – Software Issues (2023)

During planned monitoring of data post-release of Software Version 3.8.0 an increased occurrence of software issues relating to unresponsive subsystems, unresponsive user interface (sometimes referred to as a screen freeze), and/or printer disconnections was identified. The consequence of these issues would be a delay in reporting results due to the required system shutdowns to recover the system. This delay in reporting results could occur during any assay, including which the speed of the result is deemed critical or STAT and could result in a delay of treatment in a patient. Due to the release strategy of this software version, the user could not update the system but a field engineer had to manually install each affected system.

FDAOct 10, 2023Nationwide• Ortho-Clinical Diagnostics, Inc.

Compress Device Short Anchor Plug (Biomet) – Metal Burr Risk (2023)

Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery

FDAOct 9, 2023Nationwide• Biomet, Inc.

Zemits NDPrime Laser (Advance-Esthetic) – Radiation Control Violation (2023)

Advance-Esthetic LLC failed to comply with the applicable standards regarding Electronic Product Radiation Control (EPRC) regulations associated with the laser product performance standards and certification. This Recall provides correction by the firm regarding Zemits NdPrime Yag Tattoo Removal Laser. The product requires update or is missing the following in part: remote interlock connector, safety interlocks, manual reset mechanism, beam attenuator, tests for determination of compliance, certification, class IV designation and warning, labels, and labeling.

FDAOct 9, 2023Nationwide• Advance-Esthetic LLC

Spectral CT on Rails (Philips) – IVC Needle Position Issue (2023)

This recall is part of a 2-issue recall for the same system. When using the IVC needle position button, on the IVC control box during a series of scans, the plan box may not move to the desired needle position. This issue could result in the gantry moving to a location the operator does not expect. If this occurs, it presents a risk that the scan could occur at an incorrect location, or that the unintended motion of the gantry could cause a collision with the user or needle. The other part of the recall involves a software crash when the CCT foot pedal is activated (as described in RES ID93363).

FDAOct 9, 2023Nationwide• Philips North America

Spectral CT on Rails (Philips) – Software Crash Risk (2023)

When preparing for CCT Fluoroscopy mode and activating the CCT foot pedal simultaneously, the operator may experience a software crash. This would result in the system needing to be restarted.

FDAOct 9, 2023Nationwide• Philips North America

Big Bore RT CT Scanner (Philips) – Contouring Shift Risk (2023)

For oncology users: If the user performed off-set reconstruction on CT device a shift could be observed on the contouring area of the primary and secondary images sets when using image fusion (on TPS) and incorrect coordinates may be sent to TPS system when using absolute patient marking. This may lead to incorrect radiation therapy planning and possible growth or spread of cancer due to incorrect early treatment regimen. For radiology users: If the user performed off-set reconstruction on CT devices, after multiple acquisitions, the Relate Position could be inaccurate. This could lead to incorrect diagnosis and treatment.

FDAOct 9, 2023Nationwide• Philips North America Llc

Compress Device Segmental Anchor Plug (Biomet) – Metal Burr Risk (2023)

Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery

FDAOct 9, 2023Nationwide• Biomet, Inc.

Brilliance CT Big Bore (Philips) – Contouring Shift Risk (2023)

For oncology users: If the user performed off-set reconstruction on CT device a shift could be observed on the contouring area of the primary and secondary images sets when using image fusion (on TPS) and incorrect coordinates may be sent to TPS system when using absolute patient marking. This may lead to incorrect radiation therapy planning and possible growth or spread of cancer due to incorrect early treatment regimen. For radiology users: If the user performed off-set reconstruction on CT devices, after multiple acquisitions, the Relate Position could be inaccurate. This could lead to incorrect diagnosis and treatment.

FDAOct 9, 2023Nationwide• Philips North America Llc

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