Class I - Dangerous
There is a potential for separation of fiberglass resin which may cause the gantry front cover and the metal support on the cover to fail/fall
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
BD BBL Trypticase Soy Agar with 5% Sheep Blood, Catalog No. 221261, (non-selective, non-differential)
Becton Dickinson &
Class I - Dangerous
a portion of a single lot was not manufactured in accordance with the internal formulation resulting in inhibited growth of Gram negative organisms.
Class I - Dangerous
Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chevron opening compromising product sterility
Class I - Dangerous
There is a potential for separation of fiberglass resin which may cause the gantry front cover and the metal support on the cover to fail/fall
Class I - Dangerous
Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chevron opening compromising product sterility
Cascade Abrazo c-ACT-LR Test Card IVD FOR IN VITRO DIAGNOSTIC USE Store at 2 to 8 C HELENA LABORATORIES 003366 12/13(2) FOR EXPORT ONLY
Helena Laboratories
Class I - Dangerous
Due to some cards in this lot reported to have experienced variations in results, (verified by wave form), resulting in some cards with shorter or longer times than expected.
Class I - Dangerous
Potential that gauze pads may not be fully sterilized
Class I - Dangerous
The firm received complaints of the wrap coming apart and leaking granular material
Class I - Dangerous
If metal strips are removed and re-applied to another display, there is potential for the metal strips to be deformed resulting in a smaller contact surface with the front cover magnet strips. There is a risk that the protective front cover could come loose and may fall down.
Class I - Dangerous
Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chevron opening compromising product sterility
Class I - Dangerous
Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chevron opening compromising product sterility
Class I - Dangerous
There is a potential for separation of fiberglass resin which may cause the gantry front cover and the metal support on the cover to fail/fall
The firm has detected a potential risk using the command. After releasing the command, the movement of the table may continue instead of stopping.
Class I - Dangerous
The firm has implemented new product labeling changes for the Tosoh AIA-360 Analyzer. These labeling changes affect the Tosoh Quick Reference Guide, Training Manual and Training DVD previously provided by Tosoh Bioscience. These changes are being made to align the Tosoh Quick Reference Guide and associated training materials to the Operators Manual and provide clarification to the requirement that the maintenance of the B/F probe is to be performed by Tosoh a field service representative, the requirement for use of 70% Ethanol during daily shutdown procedures and the requirement for use of CAP Class 1 reagent grade water for dilution of the concentrated wash and diluent solutions and reconstitution of lyophilized reagents. Failure to follow these requirements may negatively affect system performance, lead to corrosion of instrument components over time, or result in bacterial contamination, respectively.
Artis Zee and Zeego, model no. 10272462 AXIOM Artis zee/Zeego is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
Siemens Medical Solutions USA
Class I - Dangerous
This recall has been initiated due to a possible leakage of a hose in the cooling unit of the X-ray tube. The Artis zee system may lose coolant due to a possible leakage in a hose of the cooling unit in the X-ray tube. This will cause the X-ray tube not to be sufficiently cooled down. As a result, the system will display a message Tube hot, have a break . The X-ray will be blocked several minutes later and to prevent any damage to the machine the following message will be displayed NO XRAY, TUBE TOO HOT . This issue is very sporadic and may occur during an ongoing clinical procedure. Use of this product may have a potential impact on planned procedures as they may be delayed as well as in emergent cases, as clinical treatment may need to be terminated and transferred to a functioning system.
Class I - Dangerous
Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chevron opening compromising product sterility
Class I - Dangerous
Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chevron opening compromising product sterility
Class I - Dangerous
There is a potential for separation of fiberglass resin which may cause the gantry front cover and the metal support on the cover to fail/fall
The firm received complaints of the wrap coming apart and leaking granular material
Class I - Dangerous
There is a potential for separation of fiberglass resin which may cause the gantry front cover and the metal support on the cover to fail/fall