Toshiba Aquilion CT System TSX-101A
Toshiba American Medical Systems
Class I - Dangerous
If two specific operations are performed in multi-phase helical scanning, the acquired raw data may not be saved.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
Toshiba Aquilion CT System TSX-301B
Toshiba American Medical Systems
Class I - Dangerous
If two specific operations are performed in multi-phase helical scanning, the acquired raw data may not be saved.
Synthes Screw Inserter; for use with Intramedullary Rod, orthopedic device. Used to secure the head element to the head element inserter to prevent disengagement during head element insertion.
Synthes (USA) Products
Class I - Dangerous
Certain lots of the Screw Inserter may be etched with incorrect graphics. The orientation of the etched image of the oblique angle on the Screw Inserter may not correspond to the tip of the angle of the instrument.
One Distal Access Catheter intended for distribution in Korea, was found at a US location.
Overheating and burning of the wire insulation inside the applicator.
4FR Single Lumen Pressure Injectable PICC; intravascular therapeutic catheter, for long-term use greater than 30 days.
Arrow International
Class I - Dangerous
Labeling inaccuracy in the Instructions for Use (IFU) and Patient Card. The IFU and Patient Card with these products state the PICC can withstand up to ten (10) pressure injections, however, the PICC has only been tested to withstand five (5) pressure injections.
Class I - Dangerous
In about 5% of tested samples, the outer tray was found to be compromised. Risks: A damaged outer tray detected during surgery may cause a delay in surgery to obtain another implant. If a compromised packaging is not detected prior or during a surgery by the user, it may lead to periprosthetic infection. This may result in revision or multi-stage revision to treat the infection.
Class I - Dangerous
Images may be missing when a system parameter MapRoute is set to a value greater than 1.
regard Item Number: 800524001, Sterile, LD0608A - C Section - 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: 800407001, Sterile, OR0476A - Ortho 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.
regard Item Number: 800408001, Sterile, LD0477A - C-Section 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.
SOMATOM Force; computed tomography x-ray system. Intended to generate and process cross-sectional images of patients.
Siemens Medical Solutions USA
Class I - Dangerous
Software and firmware bugs
regard Item Number: 800422, Sterile, OR0491 - Arthroscopy 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.
regard Item Number: 880327002, sterile, CV0758B - 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: 800416, Sterile, GY0485 - Robotic Hysterectomy Pkg - 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: 880323, Sterile, LD0754 - C Section - 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: 800410001, Sterile, CV0479A - Open Heart 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.
CooperSurgical LEEP REDIKIT-Used as a surgical preparatory kit for Loop Electrosurgical Excision Procedure P/N 6061
CooperSurgical
Class I - Dangerous
Kit Label incorrect :Labeled with Lidocaine HCI drug cartridges Lidocaine HCl (2%) but contains vials Lidocaine HCl (1%)
regard Item Number: 800554, Sterile, GS0643 - Pediatric Basic - 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: 800553, Sterile, OR0642 - Total Knee - 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.