In January 2010, Medtronic issued a recall of Medtronic NIM 3.0 Patient Interfaces after Medtronic identified a trend of open channel conditions (signal loss from the electrode). When the NIM 3.0 detects the signal loss from the electrode (i.e. open channel), it fails the electrode check and provides an audible and visual warning to the user which could also create a delay in the surgical procedu
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
The display on the system has the potential to change. In house testing eventually identified the unique sequence of events that must occur in order for this issue to manifest itself.
Siemens Mobilett Mira mobile x-ray system Product Usage: Mobile x-ray system
Siemens Medical Solutions USA
Class I - Dangerous
During regular product monitoring, firm became aware of a potential issue with the Mobilett Mira system, (serial numbers 1034, 1038, 1041, 1042, 1043, 1050, 1053, and 1054. During normal clinical operation the center screw on the driving wheel may become loose resulting in system immobilization. There is no risk of the system tipping over or collapsing on the floor, however the system may tilt t
CMS-8412-R2 Custom Cysto Pack containing 2 oz. bottle of PVP Prep Solution The PV contained in the kit is used in skin prep
Custom Medical Specialties
Class I - Dangerous
The firm saw on the FDA web site a recall by the manufacturer due to no microbial testing in place at the manufacturer and product did not meet proper finished goods specifications.
Class I - Dangerous
Reports of leaking during filling and administration.
Exactech Inc. of Gainesville, FL is recalling their Novation Modular Drill Bits after the devices were reported to have been used by end user while in a non-sterile condition.
CMS-2981-R3 Arthrogram Tray containing 2 oz. bottle PVP Prep Solution CMS-2981-R3 Arthrogram Tray containing 2 oz. bottle PVP Prep Solution
Custom Medical Specialties
Class I - Dangerous
The firm saw on the FDA web site a recall by the manufacturer due to no microbial testing in place at the manufacturer and product did not meet proper finished goods specifications.
Optima XR200amx. Mobile general purpose radiographic imaging of the human head and body.
GE Healthcare
Class I - Dangerous
Software issue: a violation of 21 CFR 1020.31(a). After an image is taken, when the user selects and clears an additionally displayed screen the system inhibit is also cleared, allowing the user to take an exposure without the technique factors being displayed.
The firm initiated a recall after complaint investigations revealed that when the units are left on and not in use at night and/or on weekends the hose disconnects/separates resulting in water leakage that can cause damage to property.
Exactech Inc. of Gainesville, FL is recalling their Novation Modular Drill Bits after the devices were reported to have been used by end user while in a non-sterile condition.
Exactech Inc. of Gainesville, FL is recalling their Novation Modular Drill Bits after the devices were reported to have been used by end user while in a non-sterile condition.
Exactech Inc. of Gainesville, FL is recalling their Novation Modular Drill Bits after the devices were reported to have been used by end user while in a non-sterile condition.
Class I - Dangerous
The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compromising the sterility
Class I - Dangerous
The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compromising the sterility
Class I - Dangerous
The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compromising the sterility
There is potential for the sterility of the product to be compromised.
Leakage in Cepheid SmartCycler reaction tubes.
Class I - Dangerous
Decrease in onboard dilution recovery when using Multi-Diluent 1 that has been stored on board the ADVIA Centaur and ADVIA Centaur XP systems for for BNP and TSH3 Ultra assays
Class I - Dangerous
Cracks can arise on the welded seam on the rear joint.
There have been reports of dual positive (Flu A + Flu B positive) results being encountered.