Philips AneurysmFlow. Model Number: 001015. AneurysmFlow is a software medical device (Interventional Tool) intended to be used in combination with a Philips interventional X-ray system and 3DRA d...
Reason: Potential safety issue involving the Mean Aneurysm Flow Amplitude (MAFA) ratio of AneurysmFlow (Interventional Tool). Philips has determined that the MAFA ratio does not provide re...
Reason: it was found that in versions 1.3.7, 1.4.2, and 1.4.3, the Lock Screen and Limited Access Passcode Screen on the iLet graphical user interface (GUI) include certain icons displayed...
Reason: Due to a quality issue regarding the presence of burr on the finished cervical plate product.
Z-1821-2026April 22, 2026Beaurains, N/A
THERAKOS DEVELOPMENT LIMITED
Class IIOngoing
Brand Name: Cellex Photopheresis System Product Name: CELLEX Photopheresis Kit Model/Catalog Number: CLXUSA Software Version: Not Applicable Product Description: THERAKOS Photopheresis or extracor...
Reason: Increased difficulty in installing the centrifuge bowl onto the centrifuge bowl holder. Improper installation may cause the centrifuge bowl to dislodge, resulting in a broken bowl ...
Z-1822-2026April 22, 2026Blanchardstown, N/A
Intuitive Surgical, Inc.
Class IIOngoing
Brand Name: da Vinci S, Si Monopolar Curved Scissors Instrument Product Name: da Vinci S and Si Monopolar Curved Scissors Instrument Model/Catalog Number: 420179 Software Version: N/A Product Desc...
Reason: Due to increased complaints for broken/frayed grip cables for reusable instruments.
Z-1696-2026April 8, 2026Sunnyvale, CA
Intuitive Surgical, Inc.
Class IIOngoing
Brand Name: da Vinci S, Si Permanent Cautery Hook Instrument Product Name: da Vinci S, Si Permanent Cautery Hook Instrument Model/Catalog Number: 420183 Software Version: NA Product Description: E...
Reason: Due to increased in complaints regarding frayed or broken pitch cables on reusable surgical instruments
Reason: In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths.
Z-1648-2026April 8, 2026Murrysville, PA
Intuitive Surgical, Inc.
Class IIOngoing
Brand Name: da Vinci S, Si Tenaculum Forceps Instrument Product Name: da Vinci S, Si Tenaculum Forceps Instrument Model/Catalog Number: 420207 Software Version: N/A Product Description: EndoWrist ...
Reason: Due to increased in complaints regarding frayed or broken pitch cables on reusable surgical instruments
Z-1700-2026April 8, 2026Sunnyvale, CA
Intuitive Surgical, Inc.
Class IIOngoing
Brand Name: da Vinci S, Si Mega Needle Driver Instrument Product Name: da Vinci S, Si Mega Needle Driver Instrument Model/Catalog Number: 420194 Software Version: NA Product Description: EndoWrist...
Reason: Due to increased complaints for broken/frayed grip cables for reusable instruments.
Z-1698-2026April 8, 2026Sunnyvale, CA
Intuitive Surgical, Inc.
Class IIOngoing
Brand Name: da Vinci S, Si Double Fenestrated Grasper Instrument Product Name: da Vinci S, Si Double Fenestrated Grasper Instrument Model/Catalog Number: 420189 Software Version: NA Product Descri...
Reason: Due to increased complaints for broken/frayed grip cables for reusable instruments.
Z-1697-2026April 8, 2026Sunnyvale, CA
Reflexion Medical, Inc.
Class IIOngoing
RefleXion X1 Radiotherapy System Model RXM1000, Part #800-00006-00
Reason: Due to a radiotherapy medical system software defect, when performing angular roll corrections followed by a repeat localization, the roll corrections applied in the initial locali...
Z-1656-2026April 8, 2026Hayward, CA
Philips Respironics, Inc.
Class IOngoing
Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00. Continuous home-use ventilator device.
Reason: In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths.
Z-1647-2026April 8, 2026Murrysville, PA
Philips Respironics, Inc.
Class IOngoing
Philips Respironics Trilogy Evo Universal, Software Version 1.05.15.00. Continuous home-use ventilator device.
Reason: In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths.
Reason: In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths.
Z-1646-2026April 8, 2026Murrysville, PA
Intuitive Surgical, Inc.
Class IIOngoing
Brand Name: da Vinci S, Si Grasping Retractor Instrument Product Name: da Vinci S, Si Grasping Retractor Instrument Model/Catalog Number: 420278 Software Version: NA Product Description: EndoWrist...
Reason: Due to increased complaints for broken/frayed grip cables for reusable instruments.
Reason: Product labeling includes a fetal indication for use that is not cleared under its 510(k).
Z-1631-2026April 1, 2026Saint Louis, MO
Philips Respironics, Inc.
Class IOngoing
Philips Respironics Trilogy Evo Universal, Software Version 1.05.15.00. Continuous home-use ventilator device.
Reason: Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal volume and the tidal volume received by the patient.
Reason: Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal volume and the tidal volume received by the patient.
Z-1616-2026April 1, 2026Murrysville, PA
Philips Respironics, Inc.
Class IOngoing
Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00. Continuous home-use ventilator device.
Reason: Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal volume and the tidal volume received by the patient.
Z-1615-2026April 1, 2026Murrysville, PA
AMO Puerto Rico Manufacturing, Inc.
Class IIOngoing
Brand Name: TECNIS Eyhance IOL with TECNIS Simplicity" Delivery System Product Name: TECNIS Eyhance IOL with TECNIS Simplicity" Delivery System Model/Catalog Number: DIB00 Software Version: N/A Pr...
Reason: Due to identifying a limited quantity of intraocular lenses that may have a haptic that sticks to the optic which prevents the lens from unfolding as consistently as expected.
Reason: Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal volume and the tidal volume received by the patient.
Z-1614-2026April 1, 2026Murrysville, PA
Medtronic MiniMed, Inc.
Class IIOngoing
MiniMed" 780G - MMT-1884 MiniMed" 780G - MMT-1886 With Software 6.60 and 6.61
Reason: Three software defects (Pump Error 53, BG check, and Critical Pump Error (Open Book Image)) that occurred as a result of software updates (versions 6.60, 6.61, and 6.62), which cou...
Reason: Display screen may unintentionally flicker due to a software issue. Exposure to flickering lights may induce photosensitive seizure activity in susceptible individuals.
Z-1573-2026March 25, 2026Deerfield, IL
GE Medical Systems, LLC
Class IIOngoing
Centricity Universal Viewer Software Versions 7.0 through 7.0 Sp2.0.1, a device that displays medical images (including mammograms) and data from various imaging sources, Model Numbers 5826659-027, 58...
Reason: There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer. User login credentials may be exposed on the local client workstation, w...
Z-1569-2026March 25, 2026Waukesha, WI
GE Medical Systems, LLC
Class IIOngoing
Centricity Universal Viewer Software Versions 5.0 SP6 through UV 5.0 SP7.1, a device that displays medical images (including mammograms) and data from various imaging sources, Model Numbers 2088026-02...
Reason: There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer. User login credentials may be exposed on the local client workstation, w...