Intuitive Surgical 8MM,FORCE BIPOLAR,IS4000 REF 470405 recall — FDA Z-0871-2025
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
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Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Reports of various packaging issues that may result in a breach of the sterile barrier.
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an increased potential to initiate Safety Mode during telemetry or other normal,…
GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products…
GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products…
Software defect concerning autosave mechanism may result in the clinician administering incorrect medication(s).
Reports of various packaging issues that may result in a breach of the sterile barrier.
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Gas powered emergency resuscitator has a circuit flow controller manufactured with an undersized spring, which may cause resuscitator not reach the high and low ends of the PIP and PEEP…
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 may experience a Power-on self-test error code "EA POST".
If the inflow speed is too quick, it could result in reduced outflow through the shaft due to blood, tissue fragments and kidney stone fragments, and quickly build up of intrarenal pressure.
Due to an increase in complaints for pitch cable failures related to forceps and small Graptor instruments
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Hydration issue resulting in the product being less cohesive and moldable than intended due to an issue with the polymer.
Due to an increase in complaints for pitch cable failures related to forceps and small Graptor instruments
Due to an automated dispensing cabinet software issue, when a medication single order contains more than one component and at least one is unavailable for a multi-item or combination order,…
Reports of various packaging issues that may result in a breach of the sterile barrier.
A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an increased potential to initiate Safety Mode during telemetry or other normal,…
Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products.
Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.
Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products.
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