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Showing 81–100 of 209 results

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First Source Inc: First Source iQ Flex M. Portable cart and platform that s...

Potential for the bolt that secures the positioning arm to the gas spring to come loose and fall onto patient.

FDAMay 9, 2024Nationwide• First Source Inc

First Source Inc: First Source Vision M. Portable cart and platform that su...

Potential for the bolt that secures the positioning arm to the gas spring to come loose and fall onto patient.

FDAMay 9, 2024Nationwide• First Source Inc

MEDLINE INDUSTRIES, LP Northfield: MEDLINE STERILE IRIS SCISSORS CVD/STD REF DYNJ04049 (case...

There is the potential of the tip protector to fall off 4.5" sterile, curved, Iris Scissors

Moderate

FDAApr 30, 2024Nationwide• MEDLINE INDUSTRIES, LP Northfield

FUJIFILM Healthcare Americas Corporation: FDR Visionary Suite - Intended to generate digital or con...

Bolts on the CH-200 tube may rupture due to fatigue failure, causing the tube support to fall, could result in patient injury

FDAApr 11, 2024Nationwide• FUJIFILM Healthcare Americas Corporation

Ossur H F Grjothals 5 Reykjavik Iceland: RKN130003, RHEO KNEE 3 YR WARRANTY, MD, CE, External lowe...

Due to firmware issues with the prosthetic knee, there is the potential for unintended warnings and device shutdown which could result in patient falls.

FDAMar 25, 2024Nationwide• Ossur H F Grjothals 5 Reykjavik Iceland

Ossur H F Grjothals 5 Reykjavik Iceland: RKNXC0005, RHEO KNEE XC 5 YR WARRANTY, MD, CE, External l...

Due to firmware issues with the prosthetic knee, there is the potential for unintended warnings and device shutdown which could result in patient falls.

FDAMar 25, 2024Nationwide• Ossur H F Grjothals 5 Reykjavik Iceland

Ossur H F Grjothals 5 Reykjavik Iceland: RKN130002, RHEO KNEE 2 YR WARRANTY, MD, CE, External lowe...

Due to firmware issues with the prosthetic knee, there is the potential for unintended warnings and device shutdown which could result in patient falls.

FDAMar 25, 2024Nationwide• Ossur H F Grjothals 5 Reykjavik Iceland

Ossur H F Grjothals 5 Reykjavik Iceland: RKNXC0003, RHEO KNEE XC 3 YR WARRANTY, MD, CE, External l...

Due to firmware issues with the prosthetic knee, there is the potential for unintended warnings and device shutdown which could result in patient falls.

FDAMar 25, 2024Nationwide• Ossur H F Grjothals 5 Reykjavik Iceland

GE Medical Systems, SCS: GE Healthcare Interact Discovery RT, Interventional fluo...

GE HealthCare has become aware of the potential that adhesive material might not have been applied to some bolts of certain Innova IGS, Discovery IGS, Interact IGS, Allia IGS and Allia Pulse IGS products. This could result in a potential fall of the Detector/Elevator or X-ray tube of the frontal Gantry assembly.

FDAMar 18, 2024Nationwide• GE Medical Systems, SCS

GE Medical Systems, SCS: GE Healthcare Allia IGS 7, Interventional fluoroscopic x...

GE HealthCare has become aware of the potential that adhesive material might not have been applied to some bolts of certain Innova IGS, Discovery IGS, Interact IGS, Allia IGS and Allia Pulse IGS products. This could result in a potential fall of the Detector/Elevator or X-ray tube of the frontal Gantry assembly.

FDAMar 18, 2024Nationwide• GE Medical Systems, SCS

GE Medical Systems, SCS: GE Healthcare Allia IGS 5 Pulse, Interventional fluorosc...

GE HealthCare has become aware of the potential that adhesive material might not have been applied to some bolts of certain Innova IGS, Discovery IGS, Interact IGS, Allia IGS and Allia Pulse IGS products. This could result in a potential fall of the Detector/Elevator or X-ray tube of the frontal Gantry assembly.

FDAMar 18, 2024Nationwide• GE Medical Systems, SCS

GE Medical Systems, SCS: GE Healthcare Allia IGS 7 OR, Interventional fluoroscopi...

GE HealthCare has become aware of the potential that adhesive material might not have been applied to some bolts of certain Innova IGS, Discovery IGS, Interact IGS, Allia IGS and Allia Pulse IGS products. This could result in a potential fall of the Detector/Elevator or X-ray tube of the frontal Gantry assembly.

FDAMar 18, 2024Nationwide• GE Medical Systems, SCS

GE Medical Systems, SCS: GE Healthcare Innova IGS 5, computed tomography x-ray system

GE HealthCare has become aware of the potential that adhesive material might not have been applied to some bolts of certain Innova IGS, Discovery IGS, Interact IGS, Allia IGS and Allia Pulse IGS products. This could result in a potential fall of the Detector/Elevator or X-ray tube of the frontal Gantry assembly.

FDAMar 18, 2024Nationwide• GE Medical Systems, SCS

GE Medical Systems, SCS: GE Healthcare Innova IGS 6, Interventional fluoroscopic x...

GE HealthCare has become aware of the potential that adhesive material might not have been applied to some bolts of certain Innova IGS, Discovery IGS, Interact IGS, Allia IGS and Allia Pulse IGS products. This could result in a potential fall of the Detector/Elevator or X-ray tube of the frontal Gantry assembly.

FDAMar 18, 2024Nationwide• GE Medical Systems, SCS

Raye's Inc.: SW Bari Lift & Transfer, Model Number 38060000

Retrospective engineering analysis against current ISO standards for hoists has determined: 1. The device cannot physically perform at maximum documented weight specifications when a factor of safety of two times the maximum load is applied. 2. The device is not equipped with a safety device to ensure a person with disability would not fall in the event of a single-fault condition of the lifting device.

FDAJan 25, 2024Nationwide• Raye's Inc.

SEDECAL SA PELAYA, 9 POL. POL. IND. RIO DE JANEIRO Algete Spain: Battery Mobile X-ray Unit EASY MOVING Model with telescop...

Potential interference with the anti-fall system.

FDAJan 22, 2024Nationwide• SEDECAL SA PELAYA, 9 POL. POL. IND. RIO DE JANEIRO Algete Spain

Olympus Corporation of the Americas: InstaClear Lens Cleaner-indicated for use during routine ...

Japanese IFU version had slightly different language and illustrations from the English IFU, which could contribute to the tip and plate falling off. In order to maintain consistency globally, the Japanese IFU will be updated to reflect the instructions in the English IFU

FDAJan 16, 2024Nationwide• Olympus Corporation of the Americas

Mckesson Medical-Surgical Inc. Corporate Office 9954 Maryland Drive Deep Run Iii Ste. 4000 Richmond VA 23233: Sekisui Diagnostics Control Kit OSOM BVBLUE Bacterial Vag...

Facility Critical Temperature Excursions on 08-JAN 2024 in Walk-In refrigerator due to mechanical failures, causing temperatures to fall below the validated range of 35.6 - 46.4 Degrees Fahrenheit (2 - 8 Degrees Celsius) for up to 60 minutes .

FDAJan 9, 2024Nationwide• Mckesson Medical-Surgical Inc. Corporate Office 9954 Maryland Drive Deep Run Iii Ste. 4000 Richmond VA 23233

Mckesson Medical-Surgical Inc. Corporate Office 9954 Maryland Drive Deep Run Iii Ste. 4000 Richmond VA 23233: Abbott Rapid Dx N America LLC Reproductive Endocrinology ...

Facility Critical Temperature Excursions on 08-JAN 2024 in Walk-In refrigerator due to mechanical failures, causing temperatures to fall below the validated range of 35.6 - 46.4 Degrees Fahrenheit (2 - 8 Degrees Celsius) for up to 60 minutes which could increase the probability of an incorrect test result or a delayed test result.

FDAJan 9, 2024Nationwide• Mckesson Medical-Surgical Inc. Corporate Office 9954 Maryland Drive Deep Run Iii Ste. 4000 Richmond VA 23233

Mckesson Medical-Surgical Inc. Corporate Office 9954 Maryland Drive Deep Run Iii Ste. 4000 Richmond VA 23233: Abbott Point of Care Control Control i-STAT Level 1 10 X ...

Facility Critical Temperature Excursions on 08-JAN 2024 in Walk-In refrigerator due to mechanical failures, causing temperatures to fall below the validated range of 35.6 - 46.4 Degrees Fahrenheit (2 - 8 Degrees Celsius) for up to 60 minutes which could increase the probability of an incorrect test result or a delayed test result.

FDAJan 9, 2024Nationwide• Mckesson Medical-Surgical Inc. Corporate Office 9954 Maryland Drive Deep Run Iii Ste. 4000 Richmond VA 23233

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