LeMaitre Vascular Reddick Cholangiogram Stiffer Catheter with introducer (paper IFU) REF# 2401-51
LeMaitre Vascular
Class I - Dangerous
The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
Class I - Dangerous
The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch
Toshiba Ultimax DREX-ULT80 X-ray generator
Toshiba American Medical Systems
Class I - Dangerous
It was discovered that the generator of the system could possibly terminate the exposure prematurely during an examination
Axiom Artis fluoroscopic x-ray system
Siemens Medical Solutions USA
Class I - Dangerous
A gap in the housing of the wireless foot switch could potentially result in liquids penetrating the interior. Such liquids may include disinfectants, cleaning agents and/ or bodily fluids. In rare cases, the introduction of liquids in the wireless foot switch housing could result in the failure of the foot switch.
Merge Hemo software. Product Usage: Merge Hemo is a hemodynamic monitoring system that records and displays physiological data.
Merge Healthcare
Class I - Dangerous
In some instances, the system will lock tabs within a study, even when a second user does not have the study open on a different workstation.
Class I - Dangerous
Handle may break during use.
Juno DRF; Model: 709020 Product Usage: General, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures
Villa Sistemi Medicali S.P.A.
Class I - Dangerous
Patient fell from the table because the footrest of the device detached from the table top while the patient was positioned on the table and table was moving from vertical position.
Class I - Dangerous
DHEA-S causes falsely elevated progesterone results.
Class I - Dangerous
Sterility compromised due to breach in sterile barrier
Apollo; Models: 9784000131 9784000231 9784020131 9784020231 9784100231 9784120131 9784120231 9784130131 Product Usage: General, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures.
Villa Sistemi Medicali S.P.A.
Class I - Dangerous
Patient fell from the table because the footrest of the device detached from the table top while the patient was positioned on the table and table was moving from vertical position.
The information in the EpiCenter interface translation tables was not updated to match the Bruker MALDI BioTyper database identifications for some organisms. This could lead to a possible mis-identification of an organism.
Remel, Haemophilus Test Medium (Agar) in A) 100 mm REF R01503, and B) 150 mm plates REF R04033,
Remel
Class I - Dangerous
Test organisms exhibit poor growth when grown using the test agar. The poor growth can give users incorrect AST zones when performing susceptibility tests.
Turon Impaction Fixture
Encore Medical
Class I - Dangerous
During the Turon assembly, the impaction forces caused the polymer, black acetal copolymer from the Impaction Fixture to wear off on the lateral surface of the Humeral Stem titanium plasma spray coating.
Class I - Dangerous
The firm has received complaints that the LIFEPAK 1000 Defibrillator is unexpectedly powering off during device usage.
Class I - Dangerous
DHEA-S causes falsely elevated progesterone results.
Color contact lenses labeled under the following brands: Diamond, Fierce, Ambition, Circle Collection, Lunatic, Fright, Desire and See Clear.
The See Clear Company
Class I - Dangerous
Sterility and Misbranding: Lenses may not be sterile and may be labeled with erroneous lot numbers and expiry dates.
Class I - Dangerous
The Pump Relay Printed Circuit Board Assembly (PCBA) used in the CELL-DYN Ruby instrument may prematurely fail and lead to instrument stoppage
Apollo DRF; Model: 9784220831 Product Usage: General, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures
Villa Sistemi Medicali S.P.A.
Class I - Dangerous
Patient fell from the table because the footrest of the device detached from the table top while the patient was positioned on the table and table was moving from vertical position.
Class I - Dangerous
Boston Scientific has received field reports regarding the AngioJet Ultra 5000 A Console foot switch sticking during use resulting in an undesired continued operation of the device.
PRIMUS HI and Mevatron M2/Primus Mid-Energy, Accelerator, Linear, Medical The intended use of the SIEMENS branded PRIMUS family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer
Siemens Medical Solutions USA
Class I - Dangerous
Siemens became aware of a defective weld seam at overhead suspensions. Due to this defect it is possible for the weld seam to break and to cause the overhead suspension to fall down. This can lead to a severe injury to a patient or any other person.