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Diagnostic Equipment

🏥 Medical Devices • 6,554 recalls

Olympus Ultrasound Endoscope, Model number: GF-UCT140P-AL5 - Product Usage: used with other supporting equipment for endoscopic real-time ultrasound imaging and endoscopic surgery within the gastrointestinal tract.

Olympus Corporation of the Americas

Class I - Dangerous

A new inspection step was added to the cleaning and disinfection section of the Instructions For Use (IFU) for this device in order to reduce the risk of causing patient infections.

Oct 16, 2020 Diagnostic Equipment Nationwide View Details →

CAS-930A Flat Panel Monitor (FPD) used in conjunction with the Canon Interventional Angiography System, Model numbers: Infinix-8000C and Infinix-8000H - Product Usage: This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration. The system is indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen and lower extremities.

Canon Medical System, USA

Class I - Dangerous

There is a potential that the cable of the Flat panel detector may break during a procedure which may cause the x-ray device to stop before the examination is completed. This could result in a delay with procedure and/or potential damage to the patients blood vessels due to removal without visibility.

Oct 8, 2020 Diagnostic Equipment Nationwide View Details →

The Biomeme SARS-CoV-2 Real-Time RT-PCR Test is a molecular in vitro diagnostic test that is based on widely used nucleic acid amplification technology. The Biomeme SARS-CoV-2 Real-Time RT-PCR Test contains primers and probes and internal controls used in RT-PCR for the in vitro qualitative detection of SARS-CoV-2 RNA in upper respiratory specimens. The Biomeme SARS-CoV-2 Real-Time RT-PCR Test utilizes Biomemes M1 Sample Prep Cartridge for RNA extraction, Biomemes SARS-CoV-2 Go-Strips assay, and Biomemes portable Franklin" Real-Time qPCR Thermocycler. Franklins companion mobile app, Biomeme Go, scans tests, runs PCR experiments online or offline, and is used to quickly interpret your test results while conveniently syncing data to the Biomeme Cloud. Biomeme: 1000013 (Android Smartphone w/ Biomeme Go Mobile App) and Biomeme: 1000012 (Rugged Android Smartphone w/ Biomeme Go Mobile App) are controller for Biomeme Franklin thermocycler.

Biomeme

Class I - Dangerous

The firm has become aware of nine reports by a single customer that the software made false positive calls. The investigation determined that the root cause is the higher than expected amber-to-red co-excitation in the assay.

Oct 23, 2020 Diagnostic Equipment Nationwide View Details →

MiniMed 670G, insulin pump, Ref/Model # MMT-1760KPK, MMT-1762KCN, MMT-1762WWK - Product Usage: indicated for continuous or periodic monitoring of glucose levels in the fluid under the skin, and detecting possible low and high glucose episodes. When using a sensor and transmitter, the pump displays continuous sensor glucose values and stores this data so that it can be analyzed to track patterns and improve diabetes management. This data can be uploaded to a computer for analysis of historical glucose values.

Medtronic

Class I - Dangerous

Missing solder battery connection, which could interrupt power of insulin pump.

Apr 30, 2020 Diagnostic Equipment Nationwide View Details →

Olympus Ultrasound Endoscope, Model number :GF-UM20 - Product Usage: used with other supporting equipment for endoscopic real-time ultrasound imaging and endoscopic surgery within the gastrointestinal tract.

Olympus Corporation of the Americas

Class I - Dangerous

A new inspection step was added to the cleaning and disinfection section of the Instructions For Use (IFU) for this device in order to reduce the risk of causing patient infections.

Oct 16, 2020 Diagnostic Equipment Nationwide View Details →

Olympus Ultrasound Endoscope, Model number: GF-UMQ130 - Product Usage: used with an Olympus Endoscopic Ultrasound Center, EVIS Video System Center, light source, documentation equipment, video monitor, Endo-Therapy accessories and other ancillary equipment for endoscopic ultrasound imaging of the gastrointestinal wall, biliary and pancreatic duct, and surrounding organs.

Olympus Corporation of the Americas

Class I - Dangerous

A new inspection step was added to the cleaning and disinfection section of the Instructions For Use (IFU) for this device in order to reduce the risk of causing patient infections.

Oct 16, 2020 Diagnostic Equipment Nationwide View Details →

Olympus Ultrasound Endoscope, Model number: GF-UCT180 - Product Usage: used with an Olympus universal endoscopic ultrasound center or a diagnostic system (ALOKA CO. LTD), video system center, light source, documentation equipment, monitor, EndoTherapy accessories and other ancillary equipment.

Olympus Corporation of the Americas

Class I - Dangerous

A new inspection step was added to the cleaning and disinfection section of the Instructions For Use (IFU) for this device in order to reduce the risk of causing patient infections.

Oct 16, 2020 Diagnostic Equipment Nationwide View Details →

Capnostream 35 Portable Respiratory Monitor, Product numbers PM35MN02, PM35MN01, PM35MN05, DLPM35MN02 - Product Usage: use during both no motion and motion conditions and for patients who are well or poorly perfused.

Covidien

Class I - Dangerous

The firm has released software update V01.05.02.16 (also known as V1.5.2) in response to customer reports of a false display of the message, "Temperature Exceeds Limits" followed by automatic shutdown of the monitor with no accompanying alarm.

Nov 16, 2020 Diagnostic Equipment Nationwide View Details →

Olympus Ultrasound Endoscope, Model number: GF-UM130 - Product Usage: used with an Olympus Endoscopic Ultrasound Center, EVIS Video System Center, light source, documentation equipment, video monitor, Endo-Therapy accessories and other ancillary equipment for endoscopic ultrasound imaging of the gastrointestinal wall, biliary and pancreatic duct, and surrounding organs.

Olympus Corporation of the Americas

Class I - Dangerous

A new inspection step was added to the cleaning and disinfection section of the Instructions For Use (IFU) for this device in order to reduce the risk of causing patient infections.

Oct 16, 2020 Diagnostic Equipment Nationwide View Details →

Olympus Ultrasound Endoscope, Model Number: GF-UCT140-AL5 - Product Usage: used with other supporting equipment for endoscopic real-time ultrasound imaging and endoscopic surgery within the gastrointestinal tract.

Olympus Corporation of the Americas

Class I - Dangerous

A new inspection step was added to the cleaning and disinfection section of the Instructions For Use (IFU) for this device in order to reduce the risk of causing patient infections.

Oct 16, 2020 Diagnostic Equipment Nationwide View Details →

Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF7, PROBE 60SF7 CRYOFLEX 7CM 26L - is a single use, disposable cryoprobe that is designed for use with the CryoFlex Surgical Ablation System. The probe has an integrated thermocouple for monitoring temperature at its ablation segment.

MEDTRONIC ATS MEDICAL

Class I - Dangerous

There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFlex disposables devices

Oct 12, 2020 Diagnostic Equipment Nationwide View Details →

ViewRay MRIdian System: Model No. 10000, CE, Rated Supply Voltage - 380/480 VAC, 3 - Frequency Range (Hertz) - 50/60 Hz, Rated Input in Amperes - 210 A, UDI. The MRIdian system and the MRIdian Linac system, with magnetic resonance imaging capabilities, is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.

Viewray

Class I - Dangerous

There is a potential that components of the receive coil can reach elevated temperatures which has the potential to cause a burn injury to the patient or user.

Oct 20, 2020 Diagnostic Equipment Nationwide View Details →

Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60CM1, CLAMP 60CM1 CRYOFLEX PROBE 26L - is a single use, disposable cryoprobe that is designed for use with the CryoFlex Surgical Ablation System. The probe has an integrated thermocouple for monitoring temperature at its ablation segment.

MEDTRONIC ATS MEDICAL

Class I - Dangerous

There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFlex disposables devices

Oct 12, 2020 Diagnostic Equipment Nationwide View Details →
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