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Medical Devices Recalls

Medical equipment, implants, and diagnostic devices

38,779 Total Recalls

Covidien Curity Eye Pad Oval, 1-5/8 x 2-5/8 (4.2 cm x 6.7 cm), Sterile Item Code: 2841 The sterile eye pad is a device that consists of a pad made of various materials, such as gauze and cotton, intended for use as a bandage over the eye for protection or absorption of secretions. It is supplied sterile to allow for use in the operating room, and for application to the eye following injury and or surgery in order to reduce the likelihood of introduction of infection

Covidien

Class I - Dangerous

Product sterility is compromised due to breach of sterile barrier

Mar 3, 2017 Other Medical Devices Nationwide View Details →

eCare Coordinator Product Usage: is software intended for use in data aggregation, patient interaction facilitation, storage and clinical information management with independent physiological devices and ancillary systems that are connected either directly or through networks. The software is intended to provide patient information from the patient location through networking technology to a remote care team. eCare Coordinator does not send any real time alarms and is not intended to provide automated treatment decisions. This software is an informational tool only and is not to be used as a substitute for professional judgment of healthcare providers in diagnosing and treating patients.

Philips Visicu

Class I - Dangerous

eCareCoordinator (eCC) is intended for use in data aggregation, patient interaction facilitation, storage and clinical information management with independent physiological devices and ancillary systems that are connected either directly or through networks. The software is intended to provide patient information from the patient location through networking technology to a remote care team. A software defect was discovered in the Philips eCareCoordinator (eCC) Clinical User Interface that can at times cause missing or redundant data to be saved without notification to the user.

Mar 2, 2017 Other Medical Devices Nationwide View Details →

STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da Vinci Xi Dutch SRK General and Plastic Surgery: The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Reloads and other Stapler Accessories are intended to be used with the da Vinci¿ Xi Surgical System (Model IS4000) for resection, transection and/or creation of anastomoses in General, Thoracic, Gynecologic, and Urologic surgery. The device can be used with staple line or tissue butressing material (natural or synthetic).

Intuitive Surgical

Class I - Dangerous

Intuitive Surgical has become aware and further investigation has determined that misinterpretation of instructions provided on the IS4000 Stapler Release Kit instruction card may result damage of the tool.

Mar 15, 2017 Surgical Instruments Nationwide View Details →

STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da Vinci Xi Czech SRK General and Plastic Surgery: The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Reloads and other Stapler Accessories are intended to be used with the da Vinci¿ Xi Surgical System (Model IS4000) for resection, transection and/or creation of anastomoses in General, Thoracic, Gynecologic, and Urologic surgery. The device can be used with staple line or tissue butressing material (natural or synthetic).

Intuitive Surgical

Class I - Dangerous

Intuitive Surgical has become aware and further investigation has determined that misinterpretation of instructions provided on the IS4000 Stapler Release Kit instruction card may result damage of the tool.

Mar 15, 2017 Surgical Instruments Nationwide View Details →

STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da Vinci Xi German SRK General and Plastic Surgery: The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Reloads and other Stapler Accessories are intended to be used with the da Vinci¿ Xi Surgical System (Model IS4000) for resection, transection and/or creation of anastomoses in General, Thoracic, Gynecologic, and Urologic surgery. The device can be used with staple line or tissue butressing material (natural or synthetic).

Intuitive Surgical

Class I - Dangerous

Intuitive Surgical has become aware and further investigation has determined that misinterpretation of instructions provided on the IS4000 Stapler Release Kit instruction card may result damage of the tool.

Mar 15, 2017 Surgical Instruments Nationwide View Details →

Philips IntelliVue MX4O WLAN Patient Wearable Monitor Product: 865352 Exchange part (service numbers): 453564615311 TELE PWM,802.lla/b/g,ECG only, US only 453564615331 TELE PWM,802.1 1 a/b/g,ECG&Sp02, US only Product Usage: Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults and pediatrics in hospital environments and during transport inside hospitals. The MX4O is to be used primarily as a traditional telemetry medical device. It connects to the IntelliVue Information Center by way of a wireless network. When the MX4O is connected the IntelliVue Information Center the IntelliVue Information Center provides the primary patient monitoring and alarming function. The MX4O does not automatically provide local monitoring or alarming when connected to the Information Center.

Philips Electronics North America

Class I - Dangerous

Philips lntelliVue MX4O WLAN Patient Wearable Monitor may not automatically switch to Monitor Mode with audible alarms when association with central monitoring system is unsuccessful [incomplete]

Mar 6, 2017 Diagnostic Equipment Nationwide View Details →

STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da Vinci Xi French SRK General and Plastic Surgery: The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Reloads and other Stapler Accessories are intended to be used with the da Vinci¿ Xi Surgical System (Model IS4000) for resection, transection and/or creation of anastomoses in General, Thoracic, Gynecologic, and Urologic surgery. The device can be used with staple line or tissue butressing material (natural or synthetic).

Intuitive Surgical

Class I - Dangerous

Intuitive Surgical has become aware and further investigation has determined that misinterpretation of instructions provided on the IS4000 Stapler Release Kit instruction card may result damage of the tool.

Mar 15, 2017 Surgical Instruments Nationwide View Details →

Siemens ADVIA Centaur BR assay Cat No. 02419937, SMN 10333349 (1-pack/50 tests) BR Assay for CA 27.29 The ADVIA Centaur¿ BR assay is an in vitro diagnostic test for the quantitative serial determination of cancer antigen CA 27.29 in human serum using the ADVIA Centaur¿, ADVIA Centaur¿ XP, and ADVIA Centaur¿ XPT systems. The test is intended for use as an aid in monitoring patients previously treated for Stage II or Stage III breast cancer. Serial testing for CA 27.29 in the serum of patients who are clinically free of disease should be used in conjunction with other clinical methods used for the early detection of cancer recurrence. The test is also intended for use as an aid in the management of breast cancer patients with metastatic disease by monitoring the progression or regression of disease in response to treatment.

Siemens Healthcare Diagnostics

Class I - Dangerous

Potential for the ADVIA Centaur Syphilis assay to interfere with the BR (CA 27.29) a assay on the ADVIA Centaur Systems

Mar 8, 2017 Diagnostic Equipment Nationwide View Details →

BrightView SPECT model number 882480 BrightView and BrightView X are gamma cameras designed for single or dual detector nuclear imaging accommodating a broad range of Emission Computed Tomography (ECT) studies. The cameras can be used to perform planar static, dynamic, gated, and total body studies, as well as circular-orbit and noncircular orbit SPECT studies, gated SPECT (circular and noncircular)studies, computer-programmed protocol strings, and reference scans (dual detectors only).

Philips Medical Systems (Cleveland)

Class I - Dangerous

The brake hub was not engaging with the gear box shaft due to an error in the assembly of components within the brake hub mechanism after service, causing the detector to backdrive.

Feb 24, 2017 Diagnostic Equipment Nationwide View Details →

Siemens ADVIA Centaur BR assay Cat No. 09010686, SMN 10340081 (5-pack/250 tests - REF) BR Assay for CA 27.29 The ADVIA Centaur¿ BR assay is an in vitro diagnostic test for the quantitative serial determination of cancer antigen CA 27.29 in human serum using the ADVIA Centaur¿, ADVIA Centaur¿ XP, and ADVIA Centaur¿ XPT systems. The test is intended for use as an aid in monitoring patients previously treated for Stage II or Stage III breast cancer. Serial testing for CA 27.29 in the serum of patients who are clinically free of disease should be used in conjunction with other clinical methods used for the early detection of cancer recurrence. The test is also intended for use as an aid in the management of breast cancer patients with metastatic disease by monitoring the progression or regression of disease in response to treatment.

Siemens Healthcare Diagnostics

Class I - Dangerous

Potential for the ADVIA Centaur Syphilis assay to interfere with the BR (CA 27.29) a assay on the ADVIA Centaur Systems

Mar 8, 2017 Diagnostic Equipment Nationwide View Details →

STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da Vinci Xi Turkish SRK General and Plastic Surgery: The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Reloads and other Stapler Accessories are intended to be used with the da Vinci¿ Xi Surgical System (Model IS4000) for resection, transection and/or creation of anastomoses in General, Thoracic, Gynecologic, and Urologic surgery. The device can be used with staple line or tissue butressing material (natural or synthetic).

Intuitive Surgical

Class I - Dangerous

Intuitive Surgical has become aware and further investigation has determined that misinterpretation of instructions provided on the IS4000 Stapler Release Kit instruction card may result damage of the tool.

Mar 15, 2017 Surgical Instruments Nationwide View Details →