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Infusion Pumps

🏥 Medical Devices • 4,262 recalls

CS 100i Intra-Aortic Balloon Pump

Maquet Datascope Corp - Cardiac Assist Division

Class I - Dangerous

The device failed to pump due to an electrical test failure code #58 (power up vent test fail), maintenance code #3, and an autofill failure which has been associated to a patient death due to the failure of the device to initiate therapy.

Jun 16, 2017 Infusion Pumps Nationwide View Details →

CS 100 Intra-Aortic Balloon Pump

Maquet Datascope Corp - Cardiac Assist Division

Class I - Dangerous

The device failed to pump due to an electrical test failure code #58 (power up vent test fail), maintenance code #3, and an autofill failure which has been associated to a patient death due to the failure of the device to initiate therapy.

Jun 16, 2017 Infusion Pumps Nationwide View Details →

Penumbra 3D Revascularization Device It is indicated for used in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral-M1 and M2 segments) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.

Penumbra

Class I - Dangerous

Penumbra has identified an issue in these four lots involving a raw material component of the delivery wire. This issue could result in breakage of the delivery wire, which could potentially lead to serious patient injury or death.

Jun 9, 2017 Infusion Pumps Nationwide View Details →

Merge Eye Care PACS Viewer 5.2 Merge Eye Care PACS is a software solution for the display, management, archive, interface and integration of ophthalmic device reports, images and data. Merge Eye Care PACS is a software solution using databases for patient demographics, server and other systems of intercommunication with hospital systems via HL7 and DICOM to provide to clinicians a single image viewing and management solution of images imported from various contributing devices throughout the clinical environment. Merge Eye Care PACS provides the ability to review data from any network-connected computer, and is protected by appropriate security login which permits only authorized user access. Symphony uses 256 bit or greater encryption via secure socket layer (SSL) to assure a network environment which is secure.

Merge Healthcare

Class I - Dangerous

When the user has not set up any user preference on the sorting order to render the study images (OS/OD/etc.) and reports, the ECP may get an incorrect study index. If the user attempts to delete an image, ECP may then read that image as OS when it is, in fact, OD.

Jun 13, 2017 Infusion Pumps View Details →

The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are self contained, microprocessor based infusion devices. The pumps are available in single channel and in triple channel pumping mechanism types.

ICU

Class I - Dangerous

A possible interruption of therapy when an E321 error code occurs while using the infuser, which is caused by battery issues.

Feb 1, 2013 Infusion Pumps Nationwide View Details →

The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are self contained, microprocessor based infusion devices. The pumps are available in single channel and in triple channel pumping mechanism types.

ICU

Class I - Dangerous

A possible interruption of therapy when an E321 error code occurs while using the infuser, which is caused by battery issues.

Feb 1, 2013 Infusion Pumps Nationwide View Details →

The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are self contained, microprocessor based infusion devices. The pumps are available in single channel and in triple channel pumping mechanism types.

ICU

Class I - Dangerous

A possible interruption of therapy when an E321 error code occurs while using the infuser, which is caused by battery issues.

Feb 1, 2013 Infusion Pumps Nationwide View Details →

Alaris Pump Module model 8100

CareFusion 303

Class I - Dangerous

There is a potential risk that could cause unintended flow in the older, centered sear door latch design in the Alaris Pump module model 8100.

Jun 12, 2017 Infusion Pumps View Details →

The Olympic Pasteurmatic 3000 and Olympic Pasteurmatic 3500 are intended for cleaning and high-level disinfection of respiratory therapy and anesthesia equipment by killing vegetative bacteria and viruses, in a hot water bath at ~160¿ - ~170¿ F for 30 minutes. Catalog Number/Description: 007168 PM3500 ASSY (15KW 208/120V) 007169 PM3000 ASSY (9KW 208/120V) 007169R PM3 (9KW 208/120) REFURB 007170 PM3 ASSY (8.3KW 200V DELTA) 007171 PM3 ASSY (9KW 220V SING PH) 52640 PASTEURMATIC 3000 W/O BASKETS 52640R PM 3000 w/o Baskets Refurb 52640-200 PM 3000 W/O BASKETS 200V 52640-220 PM 3000 W/O BASKETS 220V 52641 PASTEURMATIC 3000 W/BASKET S 52641R PM 3000 w/ Baskets Refurb 52641-200 PM 3000 W BASKETS 200V 52641-220 PM 3000 W/ BASKETS 220V 52650 PASTEURMATIC 3500 W/O BASKET 52651 PASTEURMATIC 3500 W/BASKETS S

Natus Medical Incorporated

Class I - Dangerous

Olympic Pasteurmatic 3000/3500 Systems are recalled because they do not fully meet todays regulatory requirements. Given the age of the products design, component and technology obsolescence, and the time involved in fully complying with the latest design and development standards, the firm decided to recall of the Olympic Pasteurmatic 3000/3500 System devices by means of disabling the devices.

May 22, 2017 Infusion Pumps Nationwide View Details →

The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are self contained, microprocessor based infusion devices. The pumps are available in single channel and in triple channel pumping mechanism types.

ICU

Class I - Dangerous

A possible interruption of therapy when an E321 error code occurs while using the infuser, which is caused by battery issues.

Feb 1, 2013 Infusion Pumps Nationwide View Details →

The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are self contained, microprocessor based infusion devices. The pumps are available in single channel and in triple channel pumping mechanism types.

ICU

Class I - Dangerous

A possible interruption of therapy when an E321 error code occurs while using the infuser, which is caused by battery issues.

Feb 1, 2013 Infusion Pumps Nationwide View Details →

The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are self contained, microprocessor based infusion devices. The pumps are available in single channel and in triple channel pumping mechanism types.

ICU

Class I - Dangerous

A possible interruption of therapy when an E321 error code occurs while using the infuser, which is caused by battery issues.

Feb 1, 2013 Infusion Pumps Nationwide View Details →

The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are self contained, microprocessor based infusion devices. The pumps are available in single channel and in triple channel pumping mechanism types.

ICU

Class I - Dangerous

A possible interruption of therapy when an E321 error code occurs while using the infuser, which is caused by battery issues.

Feb 1, 2013 Infusion Pumps Nationwide View Details →

ArjoHuntleigh Flowtron ACS900, medical pump, software V1.099 Device is used to prevent the occurrence of Deep Vein Thrombosis (DVT) in at-risk patients. The system must be used as part of a prescribed plan of car under the supervision of trained medical and/or Clinical staff. The system is intended for use only in professional healthcare facilities. It is not intended to be used in the home healthcare environment.

Arjo, Inc.

Class I - Dangerous

Reports of the device failure involving delivering continuous pressure to the calf garment and not deflating as intended, without triggering an alarm.

Jun 14, 2017 Infusion Pumps Nationwide View Details →

The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are self contained, microprocessor based infusion devices. The pumps are available in single channel and in triple channel pumping mechanism types.

ICU

Class I - Dangerous

A possible interruption of therapy when an E321 error code occurs while using the infuser, which is caused by battery issues.

Feb 1, 2013 Infusion Pumps Nationwide View Details →

The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are self contained, microprocessor based infusion devices. The pumps are available in single channel and in triple channel pumping mechanism types.

ICU

Class I - Dangerous

A possible interruption of therapy when an E321 error code occurs while using the infuser, which is caused by battery issues.

Feb 1, 2013 Infusion Pumps Nationwide View Details →

Proteus 235, Proton Therapy System Product Usage: The Proton Therapy System - Proteus 235 is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. The PTS may include a fixed small beam treatment room dedicated to the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation localized to the head and neck.

Ion Beam Applications S.A.

Class I - Dangerous

Software issue

Dec 13, 2016 Infusion Pumps View Details →
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