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Mislabeled: Product is labeled as a 20 mm X 90 mm, but is actually a 22 mm X 60 mm
Lacks a PMA or 510k.
Customers complained of bacterial contamination of lot A10-3155A.
The actual sphere power of the lens is lower than the labeled value.
Failure of the Anestar AC Main Power Switch. Battery should last 30 minutes, then ventilation and monitoring will fail.
Use of NC versions of AEM monitor presents burn hazard when used with single pad and capacitively coupled patient return electrodes.
Product 's Outer box label may not match pouch label: a 4mm x 30 mm coil may be labeled as a 9 mm x 60 mm or vice versa
Pump keyboard entries by the patient could have resulted in the patient having unintended access to programming screens and led to in improper drug dosage.
Defibrillator may fail to charge or hold its charge above energies of 75 joules
Some of the pacemakers could have failed to pace due to an inadequately soldered electrical connection at an integrated circuit.
Labels are missing an expiration date and storage instructions, increasing the likelihood that they will not be used by the expiration date or may be stored under conditions that would cause adhesive failure and loss of identity of sample or aliquot during testing.
Software defect. When Quality Assurance failure warnings are missing from a patient's report abnormal results could be used for diagnosis or treatment.
The caster/wheel may come off of the bassinet, causing the bassinet to tip.
Dead volume on sight gauge for the Synchron LX 20 and LX 20 Pro Systems not stated, which may result in instrument error.
Analyzer will produce erroneous results due to missing grounding strap.
The Low Positive Standard kit component is losing potency that may result in false positive test results.
The labeling does not instruct the removal of the protective shipping cap, and one surgeon implanted with the cap still in place.