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foreign objects (polishing stones) in the tubes
The hanger bar may detach from the jib yoke, the M8 bolt in the foot pedal assembly may come loose, and some units may have faulty actuator brackets on the mast assembly, resulting in the patient lift becoming unstable and allowing the patient to fall.
The crutches were labeled as latex free, but contain rubber in the hand grips, tips and underarm padding of the crutches.
St. Jude Medical received two complaints from customers involving the Telesheath Left Atrial Introducer System side arm detaching from the hub of the inner sheath. Subsequent testing of Telesheath inventory at St. Jude Medical indicated that the side arm from the inner sheath can detach during routine handling and manipulation, and occurs on a random basis.
The polyethylene tibial bushing was omitted from the taper of the tibial plates.
Software anomaly.
Due to a software deficiency that occurs in the combine mode, a patients image can be filmed over a different patients image.
Visual Sreen display and audible prompt may not advise to 'Press Shock'
The sunlamp products failed to incorporate a timer system and a control for termination of radiation emission in accordance with the Federal Sunlamp Product Performance Standard.
wrong introducer needle in some kits
may short circuit within the interface due to long term exposure of liquid
The detector head of a FX-80 Nuclear camera may fall from the gantry. Three potential causes have been determined. (1) A ball nut in the detector's radial drive assembly can back out of the bearing block that contains it. (2) Misalignment of the radial drive assembly. (3) Mounting bolts on the radial drive assembly may become loose, fail, or back out.
Results of tests are biased low due to a vendor change in formulation not brought to the attention of the recalling firm.
Pads may fail due to excessive corrosion of the electrode prior to the expiration date
incorrect Calibration Acceptance Limits.