Reason: Model WFB-01 sold to US customers before Aug 23, 2022 has been found to have a software bug (6 units). All WFB-01 models sold to US customers found to have labeling non-compliances...
Z-0555-2025December 11, 2024Beijing
Philips North America Llc
Class IIOngoing
Spectral CT and Spectral CT Plus. Model Numbers: 728333, 728340, 728344.
Reason: Potential for a plan box not updated issue during Interventional procedure with Spectral CT that may lead to a collision with the operator or with the needle placed inside the pati...
Z-0583-2025December 11, 2024Cambridge, MA
Becton Dickinson & Co.
Class IIOngoing
BD EpiCenter Single User Software Version or Model: 441007 Catalog Number: 441007
Reason: BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product serv...
Z-0584-2025December 11, 2024Sparks, MD
Becton Dickinson & Co.
Class IIOngoing
BD EpiCenter Data Management System, Multi User Software Version or Model: 440981 Catalog Number: 440981
Reason: BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product serv...
Z-0586-2025December 11, 2024Sparks, MD
LivaNova Deutschland GmbH
Class IIOngoing
Essenz HLM (Heart-Lung Machine), REF: 49-00-10, with Software
Reason: Heart-Lung Machine GUI touchscreen may go dark for 10-15 seconds, safety/performance functions remain operational before reset, control maintained through backup control panel, but...
Z-0571-2025December 4, 2024Munich
Abbott Medical
Class IIIOngoing
Merlin@home Transmitter REF EX1100 The Merlin@home" (M@h) transmitter is intended to transfer stored data from the patient s implanted heart device to Merlin.net" Patient Care Network (PCN) to fa...
Reason: Due to heart transmitter not being able to upgrade to the current software version in the field after experiencing a power interruption during a prior over-the-wire software downlo...
Z-0551-2025December 4, 2024Sylmar, CA
Zyno Medical LLC
Class IIIOngoing
Brand Name: Z-800 Infusion System Product Name: Z-800WF Model/Catalog Number: Z-800WF. The Z-800 Infusion system is intended to provide intravenous infusion of parenteral fluids, blood, and blood p...
Reason: For the Z-800WF pumps, the WiFi software was not compatible with the pump software that had been loaded in accordance with ongoing correction Z-1183-2024.
Z-0523-2025December 4, 2024Natick, MA
Securitas Healthcare LLC
Class IIOngoing
Arial Server Software Versions 11.1.4 through 11.1.6, SKU 54305, in conjunction with the Arial Mobile Application or Arial Care Giver Application
Reason: Certain software versions will not notify end users of calls initiated by call points with the Arial Emergency and Nurse Call System.
Z-0570-2025December 4, 2024Lincoln, NE
MicroSurgical Technology Inc
Class IIOngoing
Brand Name: MST Duet Reusable Handle for Single Use Heads Product Name: Reusable Handle for Single Use Heads (Forceps and Scissors) Model/Catalog Number: DFH-1028 Software Version: N/A Product Des...
Reason: Due to pin coming off of handles.
Z-0521-2025December 4, 2024Redmond, WA
Abbott Medical
Class IIIOngoing
Merlin@home with the MerlinOnDemand capability Transmitter REF EX1150 Merlin@home with the MerlinOnDemand" (MoD) capability is a transmitter configured for multiple patient use. It can receive inf...
Reason: Due to heart transmitter not being able to upgrade to the current software version in the field after experiencing a power interruption during a prior over-the-wire software downlo...
Z-0552-2025December 4, 2024Sylmar, CA
Philips Medical Systems Technologies Ltd.
Class IIOngoing
Vue PACS Diagnostic Viewer with Vue PACS client 12.1.5 to 12.2.8.454 software Model Number: 1149418 Intended use is to provide completely scalable local and wide area PACS (Picture Archiving and ...
Reason: A software issue affecting Philips Vue PACS may cause incorrect ischemic map and table value calculations when using the export function in the Perfusion Application for a Siemens ...
Z-0497-2025November 27, 2024Haifa, N/A
Olympus Corporation of the Americas
Class IIOngoing
Brand Name: EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190 Product Name: Olympus GIF-1TH190 Model/Catalog Number: GIF-1TH190 Software Version: N/A Product Description: This instrument is in...
Reason: To better define the drying procedures described in the IFU to improve the instructions for easier understanding of each drying step after human errors and concerns were identified...
Z-0498-2025November 27, 2024Center Valley, PA
Draeger Medical, Inc.
Class IOngoing
Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software Version: Not applicable Component: Not applicable
Reason: The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
Z-0304-2025November 20, 2024Telford, PA
Draeger Medical, Inc.
Class IOngoing
Brand Name: Atlan Product Name: Atlan A350XL Model/Catalog Number: 8621600 Software Version: Not Applicable Component: Not applicable
Reason: The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
Z-0305-2025November 20, 2024Telford, PA
Olympus Corporation of the Americas
Class IIOngoing
Brand Name: Olympus Product Name: Cystoscope Outer Sheath Model/Catalog Number: WA22810A Software Version: N/A Product Description: Outer sheaths can be combined with rigid Telescopes. Component:...
Reason: Olympus is removing the statement of compatibility with a GreenLight Laser for BPH therapy from the Instruction for Use (IFU) due to the potential for a damaged tip during use of a...
Z-0351-2025November 20, 2024Center Valley, PA
Topcon Medical Systems, Inc.
Class IIOngoing
The IMAGEnet 6 Ophthalmic Data System is a software program that is intended for use in the collection, storage and management of digital images, patient data, diagnostic data and clinical informatio...
Reason: The overlay of visual field test locations on a probability map, as presented in IMAGEnet 6 in the so-called "Hood Report", is not appropriate as it can imply a structure/function...
Z-0362-2025November 20, 2024Oakland, NJ
Baxter Healthcare Corporation
Class IIOngoing
Baxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009
Reason: The door on the Spectrum IQ Infusion pump may not be able to fully close.
Reason: Exposure of the UroPass product to Ultraviolet ( UV ) Radiation can cause brittleness of the device dilator tip, which may lead to broken dilator tips in the package or in patients...
Z-0364-2025November 20, 2024Center Valley, PA
SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
Class IIOngoing
The FLUOROspeed is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a flat detector, it can perform a range of applications including gener...
Reason: X-ray R/F system software with certain versions of the control board may occasionally fail to display images when switching from Fluoroscopy mode to Radiography mode, which may lea...
Z-0317-2025November 13, 2024Kyoto, N/A
SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
Class IIOngoing
SONIALVISION G4 is a multi-purpose X-ray R/F system. The equipment is suitable for radiographic and fluoroscopic examinations, including general radiography and pediatric examinations, excluding mammo...
Reason: X-ray R/F system software with certain versions of the control board may occasionally fail to display images when switching from Fluoroscopy mode to Radiography mode, which may lea...
Reason: Due to packaging damage from heat exposure during shipping/transportation that may result in a breach in the sterile barrier.
Z-0283-2025November 6, 2024Scottsdale, AZ
Boston Scientific Corporation
Class IIOngoing
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EU + ROW; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracar...
Reason: Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral Imaging Catheter was c...
Z-0104-2025October 23, 2024Maple Grove, MN
Boston Scientific Corporation
Class IIOngoing
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM JAPAN; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracardia...
Reason: Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral Imaging Catheter was c...
Z-0099-2025October 23, 2024Maple Grove, MN
Boston Scientific Corporation
Class IIOngoing
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EVAL EU + ROW; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or int...
Reason: Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral Imaging Catheter was c...
Z-0106-2025October 23, 2024Maple Grove, MN
Boston Scientific Corporation
Class IIOngoing
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM US; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracardiac a...
Reason: Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral Imaging Catheter was c...