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Medical device and health technology recalls from FDA. Includes diagnostic equipment, implants, monitors, and therapeutic devices.
System software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above 240 beats per minute.
System software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above 240 beats per minute.
System software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above 240 beats per minute.
System software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above 240 beats per minute.
System software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above 240 beats per minute.
System software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above 240 beats per minute.
May operate solely in reverse mode, not operate in reverse mode when intended, not function or an unintentionally start.
"The orientation of images is displayed incorrectly. When operator chooses gantry on the right side from operation console, and the patient position is HFDL, HFDR, FFDL or FFDR, the patient position picture and text is not consistent. "L" and "R" of scan images are reversed and this is not consistent with the patient actual position. "When a surview which is longe
Device fails to discharge the defibrillation energy.
Light Commercial Heat Recovery Ventilators are designed to exchange air between the inside and outside of a building or home in order to provide fresh air. The recall includes the following brand names and model numbers: Brand Model Number Flair 150/300 Compact, 300/600 Compact Venmar 6LC, HRV600i, 12LC, HRV1200i PrepAir PrepAir600i, PrepAir1200i vanEE 6LC, 12LC Carrier 62AA-064---101XX, 62AA-127---101XX York VIXRDXXA01 Heil VRC 300 Compact, VRC 600 Compact Aston HRV600i, HRV1200i Broan HRV650, HRVl150 Venmate 600H, 1200H The "X" in the model number can be either a letter or a number. The model number is written on a silver or black label on the outside panel.
This recall involves heat recovery ventilators made between October 2006 and August 2007, and have the following brand names and model numbers: Brand Models Venmar 40225 Venmar AVS 457XX, 16016XX, 43XXX, 451XX, 45400, 45709IEH, C32042 Vane 458XX, 16016XX, 43405, 43828, 45405, 45808 Rheem, Ruud, Protech 84-ERVXXX, 84-HRVXXX Carrier ERVCCLHU1200, HRVCCLHA1250, HRVCCSVU1200, ERVCCLHU1150, HRVCCLHA1150, HRVCCLVU1150, HRVCCLVU1200, HRVCCSVU1150 Bryant ERVBBLHU1200, HRVBBLHA1250, HRVBBSVU1200 Broan ERV200HC, HRV200H, HRV100H
This recall involves heat recovery ventilators made between October 2006 and August 2007, and have the following brand names and model numbers: Brand Models Venmar AEXX, EARC, 1XX, 30X, 40X, 40XXX Venmar AVS 1.X, 2.X, 30XX, 55XX Flair 30, 30XX, 55, 55XX, 85115 vänEE 10, 1XX, 100X, 20, 20XX, 30XX, 90 Conformax 300, 350, 400 NuTone NUTR130 Carrier Bryant VXXXXXXXXX, ERVXXXXXXX or HRVXXXXXXX Payne Day & Night VXXXXXXXXX Heil HEILXXXXX York 5263554XXXX Sears Brand OPTIMUM Guardian by Broan 100X, 200X Rheem Ruud Protech Weatherking 84-ERV100, 84-ERV200, 84-HRV100, 84-HRV200 The model numbers are written on a silver or black label on the outside of panel. The "X" digit used in the model numbers can be either a letter or a number.
Attic Ventilators Recalled by Westinghouse & Broan NEWS from CPSC U.S. Consumer Product Safety Commission Office of Information and Public Affairs Washington, DC 20207 Note: Phone Number Change FOR IMMEDIATE RELEASE Orginally issued March 24, 1983; Revised August 27, 2002 Release # 83-014 Westinghouse, Broan Recalling Electric Motors For Powered Attic Ventilators Washington, D.C. -- In cooperation with the U.S. Consumer Product Safety Commission, Westinghouse Electric Corporation and Broan Manufacturing Co., today announced a voluntary recall of approximately 16,000 electric motors supplied by Westinghouse for Broan Model 346 and Nautilus Model N346 attic ventilators. The ventilator motors which are miswired may, under certain conditions, overheat and cause fires. The attic ventilators were sold nationwide through electric supply houses to builders and contractors and through home centers directly to consumers. The units were manufactured and sold after April 1978. Owners should determine if they have a Broan or Nautilus roof-mounted powered attic ventilator. The ventilator can be identified from outside the house by the two foot diameter round beige plastic dome with either a Broan or Nautilus logo embossed in the top or from literature delivered with the products. If they have either model they should enter the attic to inspect the unit for model (series) 346 or N346 label on the thermostatic control or inside the dome. The motors subject to recall have a Westinghouse sticker with the model number E322P159, and are painted gray. There are also 12 rectangular holes in the bottom of the motor. Only motors with the model number E322P159 and with SER*78 or SER*79 date codes stamped on the bottom (*is any letter of the alphabet) are affected by this recall. The manufacturer has received one report of fire. No consumers have been injured. Owners are asked to copy down the motor model number and date codes before calling the toll free number given below if they have one of the suspect ventilators in their homes. Owners of the affected ventilators must disconnect or turn them off, and contact Westinghouse Electric Corporation on their toll-free number: 1-800-637-1453. A new motor will be supplied and installed by service personnel free of charge. This recall affects only Broan Model 346 and Nautilus N346 powered attic ventilators using motors with the E322P159 number and no other Broan or Nautilus powered attic ventilators with Westinghouse or other motors.