Class I - Dangerous
Outer label of some units of product number/lot number 8482, Lot 16LFS235 and product number/lot number 9414, Lot 16LUS317 do not match the drape packaged inside.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total 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.
Firm received a complaint that a customer who ordered an ADVANTA V12 7mm x 22mm x 120cm received an ADVANTA v12 7 mm x 38 mm x 80 cm, due to the manifold (catheter hub) was printed as 7mm x 38 mm x 80 cm. The complaint was the result of incorrect dimensional information (7mm x 38mm x 80cm) printed on the manifiold (catheter hub). The complaint device physical dimensions matched the dimensional information displayed on the outer packaging and the device inner pouch. This was the only complaint received for this non-conformance.
Class I - Dangerous
A small number of customer observations were recently received which related to possible unintended energy discharge with the potential to cause tissue damage to patients.
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.
Class I - Dangerous
The Doppler velocity measurement on the Sonimage HS1 ultrasound system is not accurate.
Class I - Dangerous
An issue was discovered with the Pacific Hemostasis Fibrinogen Degradation Products (FDP) kit, list number 100650, lot 948546 and FDP Latex Reagent, list 100651, lot 890199. While the kit performs accurately at FDP concentrations greater than 20 Âŋg/ml, there is an observed reduction in sensitivity when FDP levels are less than 20 Âŋg/ml. This reduction in sensitivity has been tied to FDP Latex Reagent lot 890199 and may result in false negatives.
STOCKERT Heater-Cooler System 3T, 200V/50 Hz/60 Hz
Sorin Group USA
Class I - Dangerous
Plastic heat exchanger fibers separating the blood compartment from the water compartment in certain oxygenators may allow diffusion of hydrogen peroxide in a quantity that exceeds allowable limits.
DLP Pressure Monitoring Extension Line Adapters Extends the pressure line in order to reach the pressure monitoring unit during cardiopulmonary bypass surgery.
Medtronic Perfusion Systems
Class I - Dangerous
Identification of small pinholes in a single packaging configuration of sterile pouches. A total of seven different products were affected.
DLP Extension Line Adapters 20 in length Used to extend cardioplegia line during cardiopulmonary bypass surgery
Medtronic Perfusion Systems
Class I - Dangerous
Identification of small pinholes in a single packaging configuration of sterile pouches. A total of seven different products were affected.
STOCKERT Heater-Cooler System 3T, 127V/60 Hz
Sorin Group USA
Class I - Dangerous
Plastic heat exchanger fibers separating the blood compartment from the water compartment in certain oxygenators may allow diffusion of hydrogen peroxide in a quantity that exceeds allowable limits.
PerkinElmer 226 Sample Collection Device The PerkinElmer 226 Sample Collection Device is intended to be used as a medium to collect and transport whole blood specimen spots to a laboratory in Newborn Screening.
PerkinElmer Health Sciences
Class I - Dangerous
PerkinElmer 226 Sample Collection Devices Lot Number 317114 had serial numbers printed on the pack labels that did not match the serial number range of the devices contained within the pack.
Class I - Dangerous
Pentax Medical did not always provide transformers with 9175 isolation transformers are used with 7245C, 7245C/E, 7245D, 9200Cs, 9200Ds, 9310HDs, and 9400s computer systems.
Class I - Dangerous
Pentax Medical did not always provide transformers with 9175 isolation transformers are used with 7245C, 7245C/E, 7245D, 9200Cs, 9200Ds, 9310HDs, and 9400s computer systems.
Install CD, Spine tools, Plus and S7, Version 25. Model Number 9731958.
Medtronic Navigation
Class I - Dangerous
Software issue related to the StealthStation S7 system and the Synergy Spine application Version 2.1 configured with Spine Tool Install CD version 25. Issue may result in user being unable to navigate the Navigated Elevate Inserter with the StealthAiR Spine Frame during spine surgical procedures.
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.
BD 10mL Syringe Luer-Lok Tip Catalog number 301997 The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection
Becton Dickinson & Company
Class I - Dangerous
BD identified that several lots did not receive the specified dose of irradiation necessary to meet the Sterility Assurance Level (SAL) required.
Class I - Dangerous
It was discovered that all five microwave ovens fail to have concealed or inaccessible safety interlocks.
Class I - Dangerous
An intermittent electrical problem that could lead to a loss of system power due to a loose screw connection.
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.