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Medical Devices Recalls

Medical equipment, implants, and diagnostic devices

38,779 Total Recalls

The NAV3i Platform Power Box supplies the electrical components with power (e.g. Stryker Nav3 Graphite Camera, SPC-3 Computer, IO-Tablet (touch screen) and the monitor).

Stryker Instruments Div. of Stryker

Class I - Dangerous

The Stryker NAV3i Platform Power Boxes produced between December 9, 2013 and March 7, 2014 may have been assembled without electrical insulation of the soldering joints

May 13, 2014 Diagnostic Equipment View Details →

Bard¿ Ventralight" ST Mesh with Echo PS" 4"x6" Reorder Number: 5955460 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.

Davol, Inc., Subs. C. R. Bard

Class I - Dangerous

Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal.

Apr 24, 2014 Other Medical Devices Nationwide View Details →

Cochlear Baha Soft tissue gauge 6mm. Reusable instrument used to ensure the soft tissue thickness is equal to or less than 6 mm. For use with Baha Attract hearing system.

Cochlear Americas

Class I - Dangerous

Cochlear America is recalling Cochlear Baha Soft Tissue Gauge due to possible manufacturing imperfection in the smooth surface of the metal that could potentially leave residual metal on the patient's skin.

Apr 9, 2014 Surgical Instruments Nationwide View Details →

115 V Blanketrol II, Model 222S Hyper-Hypothermia System . Used to lower or to raise a patients temperature and /or maintain a desired patient temperature through conductive heat transfer. Part number 86165.

Cincinnati Sub-Zero Products

Class I - Dangerous

The incorrect voltage component was placed into the device during manufacturing. This may make the device unable to maintain patient temperature during cooling mode. The device will continue to indicate that the unit is cooling because the compressor will continue to run, however water in the reservoir will begin to return to ambient temperature. The actual water temperature will be displayed but

Jan 8, 2014 Infusion Pumps View Details →

Bard¿ Ventralight" ST Mesh with Echo PS" 6"x10" Reorder Number: 5955610 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.

Davol, Inc., Subs. C. R. Bard

Class I - Dangerous

Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal.

Apr 24, 2014 Other Medical Devices Nationwide View Details →

Philips Medical Systems Computed Tomography X-ray systems (Brilliance CT series, iCT, iCT SP, Ingenuity CT, Ingenuity Core, Ingenuity Core128, Ingenuity Flex, and the MX8000 Dual v. EXP scanners)

Philips Medical Systems (Cleveland)

Class I - Dangerous

A customer reported that the table top had become free floating. A Field Service Engineer (FSE) confirmed that the service latch had become disengaged.

Apr 1, 2014 Diagnostic Equipment Nationwide View Details →

Bard¿ Composix" LIP Mesh with Echo PS" 8"x10" Reorder Number: 0144810 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.

Davol, Inc., Subs. C. R. Bard

Class I - Dangerous

Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal.

Apr 24, 2014 Other Medical Devices Nationwide View Details →

Arrow¿ Percutaneous Sheath Introducer Kits The Percutaneous sheath introducer products permit venous or arterial access and device introduction to the central circulation.

Arrow International

Class I - Dangerous

Arrow is recalling the Arrow¿ Percutaneous Sheath Introducer Kits due to dilator tip damage noted during internal inspection. Dilator tip damage has the potential to result in vessel damage.

Apr 14, 2014 Other Medical Devices Nationwide View Details →

ExacTrac 5.5, an Image Processing System used for patient positioning for radiation therapy or radiosurgery.

Brainlab AG

Class I - Dangerous

When using a specific plan update workflow in combination with a non-Brainlab treatment planning system (TPS), there is a possibility in ExacTrac 5.5.5 to generate an unintended blend of two initially separate plans of the same patient.

Apr 15, 2014 Other Medical Devices Nationwide View Details →

Bard¿ Ventralight" ST Mesh with Echo PS" 6"x8" Reorder Number: 5955680 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.

Davol, Inc., Subs. C. R. Bard

Class I - Dangerous

Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal.

Apr 24, 2014 Other Medical Devices Nationwide View Details →

Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. It is not intended to provide long-term patient care outside the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.

Bayer

Class I - Dangerous

There is a potential safety risk associated with potentially damaged locking pins within the bracket of non-wireless versions of Continuum systems shipped prior to March 2008.

Apr 3, 2014 Infusion Pumps Nationwide View Details →

Hologic M-IV Mammography System; Model M4--00001. Intended to produce radiographic images of the breast. For screening and diagnostic imaging of the breast.

Hologic

Class I - Dangerous

Selenia Full Field Digital Mammography System defective relay switch, if there is a need to use the emergency off switch, the system may not turn off which could result in patient injury

May 13, 2014 Diagnostic Equipment View Details →

Bard¿ Ventralight" ST Mesh with Echo PS" 6" CircleReorder Number: 5955600 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.

Davol, Inc., Subs. C. R. Bard

Class I - Dangerous

Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal.

Apr 24, 2014 Other Medical Devices Nationwide View Details →

Siemens SOMATOM Emotion 16, Emotion 6, and SOMATOM Spirit Computed Tomography Systems Product Usage: 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

The rubber damper may degrade and break, causing loosening of the motor mounting plates, which could lead to a series of events that could place the operator and patient at risk of injury.

Mar 21, 2014 Other Medical Devices Nationwide View Details →

Bard¿ Ventralight" ST Mesh with Echo PS" 8" Circle Number: 5955800 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.

Davol, Inc., Subs. C. R. Bard

Class I - Dangerous

Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal.

Apr 24, 2014 Other Medical Devices Nationwide View Details →

Liquid Mouse Monoclonal Antibody CD15 (NCL-L-CD15), a liquid tissue culture supernatant containing 15 mM sodium azide as a preservative. For in vitro diagnostic use.

Leica Microsystems

Class I - Dangerous

Product does not function as intended up to the expiry date on the product labeling. There is a link between the age of the product and staining intensity.

Jan 10, 2014 Diagnostic Equipment Nationwide View Details →

Bard¿ Ventralight" ST Mesh with Echo PS" 4.5" Circle Reorder Number: 5955450 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.

Davol, Inc., Subs. C. R. Bard

Class I - Dangerous

Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal.

Apr 24, 2014 Other Medical Devices Nationwide View Details →

Bard¿ Ventralight" ST Mesh with Echo PS TM 7"x9" Reorder Number: 5955790 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.

Davol, Inc., Subs. C. R. Bard

Class I - Dangerous

Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal.

Apr 24, 2014 Other Medical Devices Nationwide View Details →

The Stryker NAV3i Platform is a mobile cart platform consisting of the sub-components Stryker Nav3 Graphite Camera, SPC-3 Computer and IO-Tablet (touch screen) as well as the monitor, articulated arms and cart housing. This Navigation system is used in combination with surgical software for cranial, spine, ENT, orthopedic and trauma procedures.

Stryker Instruments Div. of Stryker

Class I - Dangerous

The Stryker NAV3i Platform Power Boxes produced between December 9, 2013 and March 7, 2014 may have been assembled without electrical insulation of the soldering joints

May 13, 2014 Diagnostic Equipment View Details →

Hologic Selenia Full Field Digital Mammography System: SEL-00002, SEL-00013, SEL-00030, SEL-00039. The Selenia Full Field Digital Mammography system generates digital mammography images that can be used for screening and diagnosis of breast cancer.

Hologic

Class I - Dangerous

Selenia Full Field Digital Mammography System defective relay switch, if there is a need to use the emergency off switch, the system may not turn off which could result in patient injury

May 13, 2014 Other Medical Devices View Details →