Class I - Dangerous
Examination data and patient name may be mixed up when printing or generating a pdf with the interface at Pacific Coast and Laser Institute (PCLI).
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Other Medical Devices
🏥 Medical Devices • 15,809 recalls
Kit: Blood Culture. MAI Kit Part Number: 80315D
Medical Action Industries, Inc. 306
Class I - Dangerous
Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator.
Class I - Dangerous
AquaBplus HF module on the AquaBplus 2500 osmosis system, an error in the US Installation Guideline instructed that 3-ring mains, instead of 2-ring mains, may be installed in combination with an AquaBplus 2500 device. The 3-ring main and fluid fly loops the heat disinfection may not be as effective as a 2-ring main installation
Kit: Midline Insertion DA. MAI Kit Part Number: 77981B
Medical Action Industries, Inc. 306
Class I - Dangerous
Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator.
Kit: Injection REVIEW MAI Kit Part Number: 74736
Medical Action Industries, Inc. 306
Class I - Dangerous
Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator.
VenaSeal Closure System
Medtronic
Class I - Dangerous
Firm received increased number of reports that VenaSeal dispensing systems are not effectively advancing the adhesive forward through the delivery catheter.
Kit: Blood Culture MAI Kit Part Number: 80076
Medical Action Industries, Inc. 306
Class I - Dangerous
Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator.
Class I - Dangerous
During internal Age Testing, holes were found in the sterile Tyvek pouches of the devices.
CareLink SmartSync Device Manager - Product Usage: used to treat arrhythmias related to bradycardia. Additionally, CRT-P devices can also provide cardiac resynchronization therapy (CRT) in treatment of heart failure, Model Number 24970A
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class I - Dangerous
A longevity estimation error may occur in the early years of device life when a unipolar pacing vector is programmed in the right atrial (RA) lead and/or the right ventricular (RV) lead. No other device features or therapies are impacted.
Programmers - Product Usage: used to treat arrhythmias related to bradycardia. Additionally, CRT-P devices can also provide cardiac resynchronization therapy (CRT) in treatment of heart failure. 1. 2090 Carelink 2. 29901 Encore
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class I - Dangerous
A longevity estimation error may occur in the early years of device life when a unipolar pacing vector is programmed in the right atrial (RA) lead and/or the right ventricular (RV) lead. No other device features or therapies are impacted.
Class I - Dangerous
During internal Age Testing, holes were found in the sterile Tyvek pouches of the devices.
Class I - Dangerous
During internal Age Testing, holes were found in the sterile Tyvek pouches of the devices.
Class I - Dangerous
Incorrect size printed on the device; packaging is labeled correctly.
Power Wheelchair
Merits Holdings Co.
Class I - Dangerous
Seat baseplate pin has broken in the field.
Scooter
Merits Holdings Co.
Class I - Dangerous
Seat baseplate pin has broken in the field.
InCore Lapidus Disposable Kit 28mm Left, Part Number: IC-LAP-28L - Product Usage: Intended as a three-part construct intended for internal fixation for First Metatarsocuneiform arthrodesis.
Nextremity Solutions
Class I - Dangerous
Product could potentially contain an undersized inner diameter of the 40mm drill bushing which result in not allowing the drill bit to pass through the drill bushing, causing inability of surgeon to complete surgical procedure as intended
Change Healthcare Enterprise Viewer
CHANGE HEALTHCARE CANADA COMPANY
Class I - Dangerous
Change Healthcare has identified an intermittent software defect which may result in an anchor study failing to display.
Class I - Dangerous
Users may observe additional locus specific signals at 9q34. The device pack insert indicates the probe has no known cross-reactivity to 9q34.
Artis zee ceiling-interventional Fluoroscopic X-Ray System Model Number: 10094137
Siemens Medical Solutions USA
Class I - Dangerous
Some Artis zee ceiling systems show an increased abrasion of the cabling at the cable outlet of the inner C-arm, the limited functionality may not be sufficient to continue with treatment as planned. This may result in a situation where it is necessary to cancel clinical treatment or to continue treatment on an alternative system.
Class I - Dangerous
There are cybersecurity vulnerabilities in a widely used low-level TCP/IP software library that may result in a loss of communication to the Hospital Information System/Clinical Information System (HIS/CIS).