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Data may be corrupted upon re-opening archived files.
Risk of patient entrapment, may result in serious injury or death.
The acoustic display of Mechanical Index and Thermal Index is inaccurate - two transducers may exceed limits for acoustic intensity and MI.
Mislabeled: Product may contain an incorrect needle size. Product labeled as a 25G x 1" may contain a 25G x 5/8"
Wrong size implant was mislabeled.
The sterility of the lancets may be compromised due to inadequate packaging seals.
The engager set screw may become loose. This problem may cause the potentiometer to become off-center thus affecting the end users stopping capabilities.
Mislabeled package: Package labeled as GMRS Extension Piece 60 mm, lot ZYCOC1 actually contains a GMRS Extension Piece 70 mm extension piece.
Device does not maintain a uniform internal temperature within 2-8 C at warmer ambient temperatures.
The inlet and outlet lines of the administration set may be reversed, which would result in reverse flow.
Lack of adequate manufacturing controls.
The hub of the prostate seeding needle does not release as expected from the applicator as expected during procedures.
The mounting screws of the pole clamp may come loose, allowing the pole clamp assembly to detach from the rear pump housing, if they are not maintained on at least an annual basis.
Under recovery of diluted samples by as much as 20%.
If the arm of the wheelchair is overloaded, the joystick mounting brackett and/or arm pivot may fail due to variability in the plastic used by the supplier to make the components. This failure may cause the user or a caregiver to fall if they are leaning on the arm, and result in injury.
Incidents of wire breakage in adapter cable resulting in inability to operate the defibrillator.
Automated analysis of vascular obstruction tool in software gives unreliable calibration and analysis results when using unprocessed images acquired on the Philips Allura FD10.