Z-800 Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.
Reason: Unreleased software versions were installed on distributed devices without verification or validation.
Z-1865-2025June 18, 2025Natick, MA
Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
Class IIOngoing
Brand Name: OBM00002 OBM DAB (Digital Acquisition Box) Product Name: OBM00002 OBM DAB (Digital Acquisition Box) Model/Catalog Number: OBM00002 OBM DAB (Digital Acquisition Box) Software Version: N/...
Reason: Electrode placement labels on the Digital Acquisition Box (DAB) were applied backwards. This may ultimately lead to misdiagnosis of seizure location in neonates monitored with this...
Reason: Potential for thermal incident including an unexpected occurrence of smoke, sparks, burning, or unsteady flames during clinical use. The fracturing of the fiber is the cause of, or...
Reason: A new motor/encoder and cable was introduced into instruments manufactured starting with serial number 300141 incorrectly. This incorrect installation is introducing error codes fo...
Z-1926-2025June 18, 2025Chaska, MN
Zyno Medical LLC
Class IOngoing
Z-800W Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.
Reason: Unreleased software versions were installed on distributed devices without verification or validation.
Z-1867-2025June 18, 2025Natick, MA
Tecfen Medical
Class IIOngoing
Brand Name: Tecfen Medical Product Name: 2.4mm Slit Knife, Angled Model/Catalog Number: QKN2461 Software Version: No software Product Description: This is an ophthalmic knife (manual) that is to b...
Reason: Sterility assurance for Ophthalmic knives.
Z-1951-2025June 18, 2025Santa Barbara, CA
QUANTUM SURGICAL SAS
Class IIOngoing
EPIONE Model 30-0001 UDI-DI code: 03760305400031 The EPIONE¿ device is a user controlled, stereotactic accessory intended to assist in the planning and manual advancement of one or more instrumen...
Reason: Due to a software bug the robotic arm may incorrectly guide the instrument compared to the planning defined by user.
Z-1927-2025June 18, 2025montpellier
Tecfen Medical
Class IIOngoing
Brand Name: Tecfen Medical Product Name: 20G (1.2mm) MVR Sideport Knife Straight Model/Catalog Number: QKN2312 Software Version: No software Product Description: This is an ophthalmic knife (manua...
Reason: Sterility assurance for Ophthalmic knives.
Z-1953-2025June 18, 2025Santa Barbara, CA
Tecfen Medical
Class IIOngoing
Brand Name: Tecfen Medical Product Name: 15 degree Stab Knife Model/Catalog Number: QKN1501 Software Version: No software Product Description: This is an ophthalmic knife (manual) that is to be st...
Reason: Sterility assurance for Ophthalmic knives.
Reason: A software issue was identified in the internal communication process between the system software and the X-ray generator firmware. Loss of imaging (X-ray) functionality caused by...
Z-1969-2025June 18, 2025Best
Zyno Medical LLC
Class IOngoing
Z-800WF Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.
Reason: Unreleased software versions were installed on distributed devices without verification or validation.
Z-1868-2025June 18, 2025Natick, MA
Cardinal Health 200, LLC
Class IICompleted
Kendall SCD Blended Comfort Sleeves Knee Length Small - For use with Kendall SCD SmartFlow SKU 84021B Kendall SCD Small Comfort sleeves when used with the Kendall SCD Smartflow Controller
Reason: Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatment or therapy.
Z-1919-2025June 18, 2025Waukegan, IL
Tecfen Medical
Class IIOngoing
Brand Name: Tecfen Medical Product Name: 3.2mm Slit Knife, Angled Model/Catalog Number: QKN3261 Software Version: No software Product Description: This is an ophthalmic knife (manual) that is to b...
Reason: Sterility assurance for Ophthalmic knives.
Z-1955-2025June 18, 2025Santa Barbara, CA
Ortho-Clinical Diagnostics, Inc.
Class IIOngoing
Brand Name: Solana¿ Bordetella Complete Assay Product Name: Solana Bordetella kit Model/Catalog Number: M308 Software Version: not applicable Product Description: One sales unit (kit) contains ma...
Reason: It was determined that there could be a false positive rate of up to 16.7% for the affected lots associated with the Bordetella parapertussis (BPP) results (only) of the assay.
Z-1948-2025June 18, 2025Rochester, NY
Turncare, Inc
Class IIOngoing
Brand Name: Guardian 2 System Product Name: Guardian System 2 Controller Model/Catalog Number: GS-2.5-C Software Version: 2.5.4-59 (Fix)
Reason: A software issue where "low" and "terminal" battery alerts did not display on the screen to the user in specific circumstances when the device was not running patient therapy.
Z-1967-2025June 18, 2025Pompton Plains, NJ
Tecfen Medical
Class IIOngoing
Brand Name: Tecfen Medical Product Name: 2.2mm Slit Knife, Angled Model/Catalog Number: QKN2261 Software Version: No software Product Description: This is an ophthalmic knife (manual) that is to b...
Reason: Sterility assurance for Ophthalmic knives.
Z-1950-2025June 18, 2025Santa Barbara, CA
Turncare, Inc
Class IIOngoing
Brand Name: Guardian 2 System Product Name: Guardian System 2 Controller Model/Catalog Number: GS-2.5-C Software Version: 2.5.4-69 (Fix)
Reason: A software update corrected an issue where "low" and "terminal" battery alerts did not display on the screen to the user in specific circumstances when the device was not running p...
Z-1968-2025June 18, 2025Pompton Plains, NJ
Mobius Mobility LLC
Class IIOngoing
iBOT PMD with software version 01.05.24. Personal Mobility Device.
Reason: Software issue that could potentially lead to the device tipping over from Balance Mode.
Z-1965-2025June 18, 2025Manchester, NH
Zyno Medical LLC
Class IOngoing
Z-800F Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.
Reason: Unreleased software versions were installed on distributed devices without verification or validation.
Z-1866-2025June 18, 2025Natick, MA
VIRTUAL INCISION CORPORATION
Class IICompleted
MIRA SURGICAL SYSTEM, Table mounted miniaturized electromechanical surgical system, Catalog Number MIRA-CAP-110, Software Version 4.0.3
Reason: The MIRA Surgical System Software Version 4.0.3 loaded on the Surgeon Control Console may have the potential to exhibit interrupted motion on the display screen, caused by a softwa...
Z-1905-2025June 11, 2025Lincoln, NE
Beckman Coulter, Inc.
Class IIOngoing
DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software version 1.20
Reason: A new software update (v1.20) is introducing error codes for the Dxl 9000 which prevents the assay from being performed and a delay in results from being generated, and may require...
Z-1913-2025June 11, 2025Chaska, MN
C-RAD POSITIONING AB
Class IIOngoing
Brand Name: Catalyst+ Product Name: C4D software used in conjunction with Catalyst (SP001-0025), Catalyst HD (SP001-0026), Catalyst PT (SP001-0027), Catalyst X4 (SP002-0035), Catalyst+ ...
Reason: Software issue with scanning equipment that can results in the filed rotation not being applied correctly.
Z-1858-2025June 4, 2025Uppsala, N/A
Echopixel, Inc.
Class IIOngoing
TRUE 3D VIEWER SYSTEM Model Number EP-00001-XX Software versions 1.0, 1.25, and 1.35 The t3D-Viewer is designed for use by health care professionals HCPs and is intended to assist the clinician ...
Reason: Imaging system data may be displayed with an incorrect orientation (sidedness) where the patient side is not correct (left, right, superior, inferior, anterior or posterior). This ...
Z-1807-2025May 28, 2025San Jose, CA
Echopixel, Inc.
Class IIOngoing
True 3D Viewer, Model: EP-00003
Reason: With certain software versions, import of enhanced ultrasound formatted data/ultrasound images into 3D viewer, (for digital image processing/review/analysis/communication/media int...
Z-1785-2025May 28, 2025San Jose, CA
Copan WASP
Class IIOngoing
PhenoMATRIX
Reason: AI-powered bacterial culture plate interpretation and workup software does not have Premarket Approval or pre-market notification (510(k)/de novo), so there is potential risk that ...