S4-1 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
The potential for a failed welded nut to shear off. When this occurs, the gas strut on one side of the device becomes detached from the canopy, making the canopy difficult to lift.
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) LAPAROSCOPY PACK, MODEL/ITEM NUMBER EVLP61I; 2) PELVISCOPY, MODEL/ITEM NUMBER EVPV29G.
American Contract Systems
Class I - Dangerous
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.
The potential for a failed welded nut to shear off. When this occurs, the gas strut on one side of the device becomes detached from the canopy, making the canopy difficult to lift.
c5-1 Transducer Probe
Philips Ultrasound
Class I - Dangerous
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
V6-2 Transducer Probe
Philips Ultrasound
Class I - Dangerous
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
C9-4 Transducer Probe
Philips Ultrasound
Class I - Dangerous
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
L12-5 50 Transducer Probe
Philips Ultrasound
Class I - Dangerous
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
V9-2 Transducer Probe
Philips Ultrasound
Class I - Dangerous
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
XL14-3 Transducer Probe
Philips Ultrasound
Class I - Dangerous
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
X8-2t Transducer Probe
Philips Ultrasound
Class I - Dangerous
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
C9-3io Transducer Probe
Philips Ultrasound
Class I - Dangerous
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
L11-3 Transducer Probe
Philips Ultrasound
Class I - Dangerous
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
OMNI III TEE 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 Custom loupes with Dragonfly frames
Orascoptic Surgical Acuity
Class I - Dangerous
Due to complaints, loupe nose pads containing nickel may cause an allergic reaction.
D2TCD Transducer Probe
Philips Ultrasound
Class I - Dangerous
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS STEM EXTENSION, STRAIGHT, SPLINED, SLOTTED. Canal filling stem implants.
Onkos Surgical
Class I - Dangerous
Unidentified substance of unknown impact was identified on devices during a retrospective evaluation.
Foley catheter may have an obstructed lumen, which may result in an inability to drain the bladder, of urine and may include pelvic or abdominal pain, flank pain, bladder dysfunction, obstructive uropathy, acute kidney injury and/or hydronephrosis.
Class I - Dangerous
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.
C5-2 Transducer Probe
Philips Ultrasound
Class I - Dangerous
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.