Devices with firmware versions 2.3 and lower may experience timing variations between software tasks, which could result in skipping the necessary neutral check and the wheelchair producing unintended movement upon power-up when the joystick is out of neutral.
Other Medical Devices
🏥 Medical Devices • 15,203 recalls
IDM-MULTI-R. Electrical wheelchair component.
mo-Vis BVBA
Devices with firmware versions 2.3 and lower may experience timing variations between software tasks, which could result in skipping the necessary neutral check and the wheelchair producing unintended movement upon power-up when the joystick is out of neutral.
Devices with firmware versions 2.3 and lower may experience timing variations between software tasks, which could result in skipping the necessary neutral check and the wheelchair producing unintended movement upon power-up when the joystick is out of neutral.
Potential that a component (air baffle) may be missing in some Nehalem FlexVision-2 PCs that are part of the Allura Xper series.
Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication leakage along the bag perimeter.
DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.
DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.
TRANSDUCER L12-5 Transducer Probe
Philips Ultrasound
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Medline Kits containing BD SureStep Foley Tray Systems: SKU/Description: CDS984076J GYN ROBOTIC DYNJG001004A LAVH MINOR DYNJG901001B CRANIOTOMY DYNJ908819B KIT CRANIOTOMY (only units from SKU DYNJG001004A LAVH MINOR were distributed)
MEDLINE INDUSTRIES, LP - Northfield
Kits contain SureStep Foley Tray Systems recalled by BD that include incorrect product information insert sheets. If a mislabeled tray is used, patient risk ranges from minor injury to injury that requires medical intervention, such as infection or local/systemic allergic reaction (anaphylaxis).
C6-2 Transducer Probe
Philips Ultrasound
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
L12-5 38mm Transducer Probe
Philips Ultrasound
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
C8-4v Transducer Probe
Philips Ultrasound
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Under certain conditions, such as the simultaneous use of the operating table with other medical devices, including high-frequency (HF) surgical equipment, interference may occur that could prevent the device from performing as intended. If the issue occurs, the operating table is unresponsive to command from both the universal remote control and override panel.
L9-3 Transducer Probe
Philips Ultrasound
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
X7-2 Transducer Probe
Philips Ultrasound
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
GE HealthCare OEC 9900 Elite C-arm Systems.
GE Medical Systems
GE HealthCare has become aware of a non-conformance to 21 CFR 1020.30 (k) in certain OEC 9800 and OEC 9900 Elite C-arm Systems. Specifically, impacted systems are missing the full layer of lead tape in the collimator covers, which will lead to a small increase in radiation exposure to the patient and/or operator. The missing lead tape is not detectable by the user.
Regulatory documentation error and misleading color packaging claim.
S9-2 Transducer Probe
Philips Ultrasound
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
C8-5 Transducer Probe
Philips Ultrasound
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
mC7-2 Transducer Probe
Philips Ultrasound
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.