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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.

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.

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.

Moderate

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

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.

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.

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

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

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

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.

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.

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

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

Brilliance CT Big Bore Oncology (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

ORION System (LEONI) – Unintended Movement Risk (2023)

Users of the patient positioning system ORION System can be faced with a sudden short-term acceleration or with an unintended short-distance movement when the movements are again allowed after an unforeseen interruption signal of motion may result in a collision of the patient with another stationary component of the treatment room.

FDAOct 6, 2023Nationwide• LEONI CIA CABLE SYSTEMS 5 avenue Victor Hugo Chartres France

D-Clip Applier (Peter Lazic) – Surgery Failure Risk (2023)

Customer complaint received that reported the applier failed during surgery. The applier did not release the clip. The applier remained attached to the clip.

FDAOct 6, 2023Nationwide• Peter Lazic Gmbh Immelmannweg 2 Tuttlingen Germany

Contra Gray Turbo Plus Cups (Young Dental) – Incorrect Cup Type (2023)

one lot of Contra Gray (soft) Turbo Plus Cups Dental Prophylaxis Angles may contain Contra Petite Web LF Soft Purple Cup DPAs.

FDAOct 6, 2023IN, MO, TN• Young Dental Manufacturing I, LLC

Da Vinci Needle Driver (Intuitive Surgical) – Needle Dislodge Risk (2023)

There is the potential for the needle drive to become dislodged and/or broken which could result in uncontrollable movement.

FDAOct 6, 2023CA, CO, FL +11 more• Intuitive Surgical, Inc.

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