S4-1 Lumify Transducer Probe
Philips Ultrasound
Class I - Dangerous
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
37,779 Total Recalls
S4-2 Transducer Probe
Philips Ultrasound
Class I - Dangerous
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
OMNI II TEE Transducer Probe
Philips Ultrasound
Class I - Dangerous
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
C9-2 Transducer Probe
Philips Ultrasound
Class I - Dangerous
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Akreos, SKU: AO60P0300. Akreos intraocular lenses
Bausch & Lomb Surgical
Class I - Dangerous
An off-power error was identified, which resulted in a diopter of 16, rather than the intended 3 diopter. Implantation of affected intraocular lens could result in functional visual impairment or reduction in visual acuity which could result in the need for optical or surgical correction.
3D9-3v Transducer Probe
Philips Ultrasound
Class I - Dangerous
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
L18-5 Transducer Probe
Philips Ultrasound
Class I - Dangerous
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
The defect in the thread area will not allow the device to fully engage with an implant or analog (implant replica used for prosthetic modeling). The threads will only engage approximately 2 rotations as opposed to full engagement which is approximately 5 rotations. This equates to approximately 1mm difference in depth of engagement.
Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications.
During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
D2cwc Transducer Probe
Philips Ultrasound
Class I - Dangerous
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Orascoptic Superior Visualization Dragonfly Nose Pad Accessory Kit ( nose pad and screw) 1 pk and 20 pk.
Orascoptic Surgical Acuity
Class I - Dangerous
Due to complaints, loupe nose pads containing nickel may cause an allergic reaction.
mL26-8 Transducer Probe
Philips Ultrasound
Class I - Dangerous
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
C6-3 Transducer Probe
Philips Ultrasound
Class I - Dangerous
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
eL18-4 Transducer Probe
Philips Ultrasound
Class I - Dangerous
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Class I - Dangerous
Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications.
mC12-3 Transducer Probe
Philips Ultrasound
Class I - Dangerous
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
TherMax Blood Warmer Unit-US, PrisMax Accessory, Product Codes: 955630, 955515, 955702, 955631
VANTIVE US HEALTHCARE
Class I - Dangerous
Thermax System may be unable to detect the presence of a bag on the Thermax Blood Warmer Unit leading to difficulty setting up therapy, or PrisMax System alarm T2284: Thermax Disposable Not Inserted
L15-7io Transducer Probe
Philips Ultrasound
Class I - Dangerous
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.