FDA Device Recalls

Class IICompleted

bellavista 1000e Ventilator, Catalogue Number 301.100.130; Continuous Use Ventilator

Vyaire Medical

Vyaire Medical identified two patient safety risks during the use of the bellavista 1000 and bellavista 1000e: 1. Under certain conditions of use, the touchscreen may become unresponsive and the device application stops responding (APP Hang). When this occurs, if the user continues to interact with the touchscreen, a message will appear that states DeviceSoftware.Application is not responding or a decommission screen will appear on the user interface. The ventilator will issue both an audible and visual alarm. Ventilation continues without interruption with the settings applied prior to the APP Hang error. 2. The potential for a use error has been identified if the operator applies the proposed settings without confirming the settings are suitable for the patient.

May 5, 2023 · DeviceView details →

ProPlan CMF Patient-Specific Guide, Mandible guides (3A & 3B)-Intended to guide the marking of bone and/or guide surgical instruments in mandibular and maxillofacial surgical procedures. Identification number: SD900.101

LVP software of the Ivenix Infusion System (IIS); LVP-SW-0004

bellavista 1000e Ventilator, Catalogue Number 301.100.130; Continuous Use Ventilator

bellavista 1000 Ventilator, Catalogue Number 301.100.030; Continuous Use Ventilator

MRI Biomet Pin Guide for Total Knee Arthroplasty (Zimmer Biomet Patient Specific Instruments (PSI)-- patient-matched device designed to fit the patients anatomy to transfer a patient-specific pre-operative plan to the OR. Ref: KNM-ZB02-00-01

Cytrellis ellacor System with Micro-Coring Technology-Dermal Micro-Coring System System intended for the treatment of moderate and severe wrinkles in the mid and lower face. Model #: Gen 4

MiSeq Dx Instrument, Catalog # M70101, containing Universal Copy Service (UCS) software.

NextSeq 550Dx Instrument, Catalog # 20005715, contaning Universal Copy Service software

greiner bio-one VACUETTE TUBE 6 ml K3E K3EDTA, 13x100 pink cap-black ring, non-ridged, 24 racks of 50 pcs., 1200 pcs in total, Item #456003

Immundiagnostik IDK Lactoferrin ELISA- In vitro enzyme immunoassay intended for the determination of lactoferrin in stool. P/N: K6870 Single Kit P/N: K6870.20.US.L 20 Plates

ADVANCED RESEARCH MEDICAL Lumbar Interbody Fusion System (OLLIF), Flexible Curette Loop Blade, Part # 01-06-4; treatment of degenerative disc disease

Quantum Perfusion Systems for CPB, Roller Pumps use peristaltic action to propel blood through the venous and arterial circuit tubing. Catalog Numbers: a) 51-000013-00, b) 51-000008-00

MectaLIF ANTERIOR - Lag Plate Flush H10, REF 03.30.300, interbody fusion device

MectaLIF ANTERIOR - Lag Plate Flush H14, REF 03.30.302, interbody fusion device

MectaLIF ANTERIOR - Antibackout Lag Cover, REF 03.30.305, interbody fusion device

MectaLIF ANTERIOR - Lag Plate Flush H18, REF 03.30.304, interbody fusion device

MectaLIF ANTERIOR - Lag Plate Flush H12, REF 03.30.301, interbody fusion device

MectaLIF ANTERIOR - Lag Plate Flush H16, REF 03.30.303, interbody fusion device

RelieVR REF: RVX-2002, Rx Only. Virtual reality behavioral therapy device for pain relief.

FreeStyle Libre 3 App, part of Continuous Glucose Monitoring System, when used on the Android 13 Operating System