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The catheter tubing included in the kit may break during removal.
Image orientation and orientation markers may not match when an image is rotated or flipped when the CT Image is preset.
The repair program involves only the roof glass in sunrooms (including skylights installed as part of the sunroom) that reflect sunlight onto nearby cedar shingles or cedar shakes. It involves reflective Code 77 roof insulating glass units. It includes new sunrooms sold from 1996 through 2002, but possibly constructed later, and those sunrooms, regardless of when built, that had roof glass or skylights replaced with Code 77 glass from 1996 to 2005.
A c-clip located near the rasp connection end of the instrument may detach during use and fall into the patient.
The Paceart System could inappropriately insert data from a patient's Medtronic CareLink transmission into another patient's Paceart record. An issue associated with the automated batch transfer of implanted cardiac device data from the Medtronic CareLink network to the Paceart System exists.
Internal testing revealed that some of the sensors might not meet the accuracy specifications of : 2% for SpO2 and of: 3% for SpCO, due to the tolerance of one of the emitter LED's used in the calculation ofSpO2 and SpCO. The SpO2 reading may have a negative bias of up to 1 % and the SpCO reading may have a negative bias of up to 4%.
The BP/Notch filter may be out of specification and may cause injury to the patient's eye due to high power (energy) delivered by the Laser System during medical procedures.
The recalled walkers have eight wheels and are sold in various colors including dark blue, pink and white, or pink and red. The activity trays on the baby walkers have a steering wheel, various rattles and a mirror or animal themes. The trays play music when the baby pushes a button. "Baby" is printed on a sticker on the tray or the walker's base.
The recalled walkers are intended for babies 6 months and older. The walkers are blue, green, pink and yellow. They have musical activity trays with various toys and themes including rockets and a tank with an army print cloth seat, lights and a steering wheel with a teddy bear cloth seat, and a monkey's face with a teddy bear seat cloth. "Baby" and "BEBELOVE" are printed on labels on some of the walkers.
Weil-McClain GV water boiler Models GV-3, GV-4, GV-5 and GV-6 with a serial number/date code range of CP5075477 to CP5221234 and built from April 1, 2005 through October 31, 2005. Serial numbers and date codes are located on the left side of the jacket, above the boiler rating label.
Knee Navigation Disposable Kits were programmed with an incorrect identification number on the tracker ROM chip which would not permit navigation during surgery.
Component leads may have intermittent connection to the printed circuit board assembly pads - which could render the device inoperative.
DESA 40-80,000 BTU Portable Propane Convection Heaters generate from 40,000 to 80,000 BTUs an hour. The following model names and number are involved in this recall: Reddy Heater (RCP80VC), All-Pro (SPC-80CC), MASTER (TC80VC), Universal (80-CC), and Dayton (6BY73). These heaters have serial numbers between 017390000 and 017632220. The model and serial numbers are on the carton and on labels attached to the heater. The designation "Made in China" is on the carton and model label attached to the heater.
The recalled walkers have eight wheels and an activity tray with interactive toys. The walkers are blue and pink with various designs on the cloth seat. "Imported by Ace Han Corp" is printed on labels located on the base of the walkers.
A false negative result may be reported.