IntelliVue Patient Monitor MX700. Product Number: 865241.
Philips North America
Class I - Dangerous
Potential issue where the IntelliVue monitors did not alarm.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
37,779 Total Recalls
CT 5300; Software Version Number: 4.5, 5.0, 5.1;
Philips North America
Class I - Dangerous
If the screws of tube heat exchanger on the rotating scanner are not tightened well after replacing. This component may become detached and make contact with other components located within the Incisive CT systems during rotation. Other components could be damaged due to the contact with the tube heat exchanger.
Urinary Tract Infection Test
GET TESTED INTERNATIONAL AB
Class I - Dangerous
Distribution without premarket approval/clearance.
IntelliVue Patient Monitor MX500. Product Number: 866064.
Philips North America
Class I - Dangerous
Potential issue where the IntelliVue monitors did not alarm.
Lactose Intolerance Test
GET TESTED INTERNATIONAL AB
Class I - Dangerous
Distribution without premarket approval/clearance.
Class I - Dangerous
Fibula nail system intended for use in fixation of fibular fractures and osteotomies, has out of specification thread depths on the fibula nail, so implant may not be able to mate properly with the associated mounting bolt. If nail (implant) cannot properly mate with instrumentation, the surgery potentially will need to be aborted.
PSA Test
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Class I - Dangerous
Distribution without premarket approval/clearance.
IntelliVue Patient Monitor MX850. Product Number: 866470.
Philips North America
Class I - Dangerous
Potential issue where the IntelliVue monitors did not alarm.
Gut Microbiome Test Small
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Class I - Dangerous
Distribution without premarket approval/clearance.
8 in 1 STI Test Kit
GET TESTED INTERNATIONAL AB
Class I - Dangerous
Distribution without premarket approval/clearance.
Akkermansia Test
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Class I - Dangerous
Distribution without premarket approval/clearance.
MAMMOMAT Inspiration;
Siemens Medical Solutions USA
Class I - Dangerous
There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary operation only.
Food Intolerance Test Medium
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Class I - Dangerous
Distribution without premarket approval/clearance.
KWIK-STIK, Quality control kit for culture media, Vibrio parahaemolyticus derived from ATCC 17802, Catalog Number 0818K
Microbiologics
Class I - Dangerous
Some products packaged for lot 818-111-7 may have been packaged in pouches labeled as lot 857-53-10.
MAMMOMAT Fusion;
Siemens Medical Solutions USA
Class I - Dangerous
There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary operation only.
IntelliVue MP2. Product Number: M8102A.
Philips North America
Class I - Dangerous
Potential issue where the IntelliVue monitors did not alarm.
Food Sensitivity Test Large
GET TESTED INTERNATIONAL AB
Class I - Dangerous
Distribution without premarket approval/clearance.
IVENIX INFUSION SYSTEM, LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Large Volume Infusion Pump Administration Set.
Fresenius Kabi USA
Class I - Dangerous
Incorrect assembly of specific lot of LVP Primary Administration Set that could result in serious patient injury.
Mycotoxin Panel Test
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Class I - Dangerous
Distribution without premarket approval/clearance.
Food Sensitivity Test Small
GET TESTED INTERNATIONAL AB
Class I - Dangerous
Distribution without premarket approval/clearance.