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Medical device and health technology recalls from FDA. Includes diagnostic equipment, implants, monitors, and therapeutic devices.
The Handpiece Adaptor may have a manufacturing defect causing incorrect geometry. The incorrect geometry in turn causes the Handpiece Adaptor to not fit onto the doctor's dental handpiece.
Customer complaints were received regarding falsely elevated results for some patient samples. Internal studies with customer return samples confirmed potential interactions that may lead to falsely elevated results when processed as below on the same instrument: " ARCHITECT Syphilis TP (LN 8D06) and/or ARCHITECT AdviseDx SARS-CoV-2-IgG II (LN 6S60) precedes ARCHITECT Anti-HCV testing (LN 1L79). " Alinity i Syphilis TP (LN 07P60) precedes Alinity i Anti-HCV testing (LN 08P05).
Update to contraindications and warning language due to CPAP masks containing magnets.
Update to contraindications and warning language due to CPAP masks containing magnets.
Potential for a leak path at the seal interface between the left ventricle assist system inflow cannula and the titanium apical cuff.
Potential for positively biased results due to signal reduction over shelf life.
Update to contraindications and warning language due to CPAP masks containing magnets.
Update to contraindications and warning language due to CPAP masks containing magnets.
Due to increase in complaints for the KD-640L and KD-645L Triangle Tip Electrosurgical Knives breaking off during use -issuing reminder to users to utilize the electrosurgical knife in accordance with the Instructions for Use, which details critical specifications regarding electrosurgical unit compatibility and output due to reports of serious injury
These laser products fail to comply with 21 CFR 1040.10(f)(4) Key control which requires, Each laser system classified as a Class IIIb or IV laser product shall incorporate a key-actuated master control. The key shall be removable and the laser shall not be operable when the key is removed. , because while the laser is switched on, the key can be removed from the key switch. The correction is replacement with a key switch that captures the key when in the on position.
These laser products fail to comply with 21 CFR 1040.10(f)(4) Key control which requires, Each laser system classified as a Class IIIb or IV laser product shall incorporate a key-actuated master control. The key shall be removable and the laser shall not be operable when the key is removed. , because while the laser is switched on, the key can be removed from the key switch. The correction is replacement with a key switch that captures the key when in the on position.
Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
These laser products fail to comply with 21 CFR 1040.10(f)(4) Key control which requires, Each laser system classified as a Class IIIb or IV laser product shall incorporate a key-actuated master control. The key shall be removable and the laser shall not be operable when the key is removed. , because while the laser is switched on, the key can be removed from the key switch. The correction is replacement with a key switch that captures the key when in the on position.
There is a potential that the Cholestech LDX battery (an external battery pack available as an optional accessory to the Cholestech LDX Analyzer) may swell which could cause minor burns, cuts or abrasions, or low current electrical shock to the user.
Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
Update to contraindications and warning language due to CPAP masks containing magnets.
Trumpet Needle Guide ring can detach when excessive pressure is applied.
Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
Trumpet Needle Guide ring can detach when excessive pressure is applied.