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Other Medical Devices

🏥 Medical Devices • 15,809 recalls

Bard¿ Composix" LIP Mesh with Echo PS" 7"x9" Reorder Number: 0144790 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 →

Toshiba Infinix X-Ray Interventional System INFX-8000V/UU. An X-Ray system that is capable of radiographic and fluoroscopic studies used in an interventional setting.

Toshiba American Medical Systems

Class I - Dangerous

Although the Flat Panel Detector (FPD) touch sensor is activated during use, the error message is displayed and the audible signal continues sounding during the table movement of longitudinal tilt, the movement of longitudinal tilt does not stop.

May 12, 2014 Other Medical Devices Nationwide View Details →

Composix" LP with Echo PS" 10x13 HUXH0294 HUXL0314 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" 10"x13" Reorder Number: 5955113 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 →

Composix" LP with Echo PS" 6x8 Reorder Number: 0144680 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" 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 →

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 →

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 →

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 →

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 →

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 →

Visitec Anterior Chamber Cannula, .40x22mm (27Gx7/8in) REF 585006 Cannulae are intended to irrigate and or aspirate ophthalmic solutions and liquids in or out of the eye, and remove materials where appropriate. These products are used in all sections of the eye. This cannula is a general use cannula mainly designed for the precise maintenance of optimum anterior chamber depth

Beaver-Visitec International

Class I - Dangerous

Contains a sharp tip needle when the product should contain a blunt tip cannula

May 6, 2014 Other Medical Devices Nationwide View Details →

LIFEPAK 1000 defibrillator. Affected Part Numbers: 320371500XXX The LP1000 (in AED mode) is indicated for use on patients in cardiac arrest.

Physio-Control

Class I - Dangerous

Physio-Control has become aware of incidents where customers have attempted to use their LIFEPAK 1000 defibrillator and the device has shut down unexpectedly due to a very low battery. A defibrillator in this scenario has the potential to fail to deliver a shock, with the potential result that therapy is not delivered and a patient is not resuscitated. A software malfunction in the LIFEPAK 100

May 9, 2014 Other Medical Devices Nationwide View Details →

Anspach Irrigation Clip 40 Product Usage: Irrigation clips provide a method of supplying controlled, cooling irrigation during cutting, shaping, and removal of bone, including bones of the skull and spine.

The Anspach Effort

Class I - Dangerous

The Irrigation Clips were assembled with the incorrect (smaller) clips.

Dec 3, 2013 Other Medical Devices Nationwide View Details →

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