Class I - Dangerous
Dose and MU are incorrect when CT images are viewed from the head, and, when using multiple prescriptions with forced densities.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
SOMATOM Definition Flash; intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles.
Siemens Medical Solutions USA
Class I - Dangerous
software bug issues for SW-Version VA48A_SP0. The following safety issues were resolved: 1) Correction to improve visual warning and error indication son the gantry display. 2) Correction to improve acquisition data in order to optimize image quality. 3) Correction to improve robustness and general system behavior in some exception handling procedures. 4) Correction to improve auto post processin
regard Item Number: 800569, Sterile, CV0659 - Open Heart A & B - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
Resource Optimization & Innovation
Class I - Dangerous
The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
regard Item Number: 800414, Sterile, OR0483 - Total Joint Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
Resource Optimization & Innovation
Class I - Dangerous
The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
Class I - Dangerous
Image disappeared from the cardiac ultrasound system when the CARTO 3 EP Navigation System needed restarting while the patient was experiencing pericardial effusion. Affects the CARTOSOUND Module of the CARTO 3 EP Navigation System when used with the SOUNDSTAR eco 8F and 10F Diagnostic Ultrasound Catheters. New precautions added.
Class I - Dangerous
Product labeling of these sterile guide wires (external carton label and patient record label) states a 10-year expiration date. Package testing supports a 5-year expiration date for these same guide wires.
ASP-1021 LipoTower with Aspiration Pump and Tumescent Pump. Medical use.
MicroAire Surgical Instruments
Class I - Dangerous
There is potential risk of electrical shock if lead wires inside the device become detached and the ground connection fails.
Sterilmed, Inc. is recalling its reprocessed Zimmer Tourniquet Cuff, Part #ZIM60-7075-106, lot number 1846885 due to mislabeling. The affected reprocessed product is labeled as single hose devices but the devices inside the packaging are dual hose devices.
Ferno iNX Wheeled Stretcher, Integrated Patient Transport & Loading System Product Usage: Stretcher for pre-hospital patient transport.
Ferno-Washington
Class I - Dangerous
Hole elongation in the telescoping load frame channel. A hole elongation could affect the ability of the retention pin to stay seated which is necessary to preclude movement of the telescoping load frame.
Philips GoSafe Mobile Help Button; 7000MHB. Personal Emergency Response System.
Lifeline Systems, Incorporated
Class I - Dangerous
Irregular battery disconnection resulted in issues with Mobile Health Button (MHB) Charging.
Specific use conditions can increase the possibility of a screwdriver tip deforming or breaking during surgery.
Class I - Dangerous
Image disappeared from the cardiac ultrasound system when the CARTO 3 EP Navigation System needed restarting while the patient was experiencing pericardial effusion. Affects the CARTOSOUND Module of the CARTO 3 EP Navigation System when used with the SOUNDSTAR eco 8F and 10F Diagnostic Ultrasound Catheters. New precautions added.
PROFEMUR PLUS CoCr MODULAR NECK, REF: PHAC1254, SIZE LONG, ORIENTATION 8 degree VAR/VAL. 12/14 SLT Taper. Orthopedic hip prosthesis component.
MicroPort Orthopedics
Class I - Dangerous
Unexpected rate of postoperative fractures resulting in the need for revision surgery.
Class I - Dangerous
The company has determined the sterility cannot be assured for the affected lot.
EVIS EXERA II Gastrovideoscope OLYMPUS GF type UCT180; designed for endoscopic real-time ultrasound imaging, ultrasound guided needle aspiration and other endoscopic procedures within the upper gastrointestinal tract and surrounding organs.
Olympus Corporation of the Americas
Class I - Dangerous
Insufficient information for specific cleaning accessories used for the cleaning and reprocessing of the GF-UCT180 ultrasound endoscope
Specific use conditions can increase the possibility of a screwdriver tip deforming or breaking during surgery.
ASP-1020 LipoTower with Aspiration Pump. Medical use.
MicroAire Surgical Instruments
Class I - Dangerous
There is potential risk of electrical shock if lead wires inside the device become detached and the ground connection fails.
Arrow Kits with Medtronic Covidien 0.9% Sodium Chloride Flush Syringes
Arrow International
Class I - Dangerous
Manufacturer of 0.9% Sodium Chloride Flush Syringes recalled due to compromised sterility of the outer barrel, Arrow purchased recalled items that were packaged with certain products.
RAPIDPoint 500 measurement cartridge serial numbers 2517102517 through 2519000012, negative sodium bias on both QC and patient results
Class I - Dangerous
The 00-0903-2510, 3.5mm x 10mm Non Locking Cortical Screw, Lot # 150192-J package may contain a different screw. The screw in the package is a 00-0903-2526, 3.5mm x 26mm, and is etched correctly.