NM/CT 850 Model Number: H3907AD
GE Healthcare
Class I - Dangerous
Rotor bearing screws were found loose on detector.
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Other Medical Devices
🏥 Medical Devices • 15,203 recalls
Class I - Dangerous
Reagents were shipped to customers after the Use by data indicated on its labeling.
Central Line Dressing Change Tray
Medline Industries
Class I - Dangerous
Potential of incomplete seals impacting the sterility of the kit.
Discovery NM 630 Model # H3101RH
GE Healthcare
Class I - Dangerous
Rotor bearing screws were found loose on detector.
EVOLVE STEM 8.5MM Model # 496S085
Wright Medical Technology
Class I - Dangerous
Lack of sterility assurance
Discovery NM670 Pro Model # H3100XB
GE Healthcare
Class I - Dangerous
Rotor bearing screws were found loose on detector.
NM/CT 870 DR Model # H3100AS
GE Healthcare
Class I - Dangerous
Rotor bearing screws were found loose on detector.
BECKMAN COULTER ACCESS Immunoassay Systems - Access Unconjugated Estriol, REF 33570.
Beckman Coulter
Class I - Dangerous
Due to alkaline phosphatase (ALP) associated interference causing falsely elevated uE3 (Unconjugated Estriol assay) results.
NM/CT 870 CZT Model # H3906CW
GE Healthcare
Class I - Dangerous
Rotor bearing screws were found loose on detector.
Class I - Dangerous
Tube trays may leak which could invalidate patient results or assay worklists, causing delayed results for any assays with which they are used. A possibility exists of false negative result with flu A/B/RSV assay or paraflu assay.
NM 830 Model # H3910AC
GE Healthcare
Class I - Dangerous
Rotor bearing screws were found loose on detector.
Discovery 670 DR Model # H3100BT
GE Healthcare
Class I - Dangerous
Rotor bearing screws were found loose on detector.
NM/CT 860, SPECT/CT
GE Healthcare
Class I - Dangerous
Rotor bearing screws were found loose on detector.
Class I - Dangerous
The firm has received reports concerning the patient fiducial disk separating from the body and users attempting to re-assemble the device. The use of a re-assembled patient fiducial could lead to inability to navigate or inaccuracies such as improper needle trajectory.
May contain excess glue within the handle of the delivery system, resulting in an inability to fully deploy the graft via the standard method or troubleshooting deployment method provided in the IFU
AVANOS MIC-KEY SF Gastrostomy Feeding Tube
Avanos Medical
Class I - Dangerous
Devices had cracked or detached from the feeding tube body
Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 1/4x3/32, Catalog Number 5791 - Product Usage: intended for use with Terumo and Sarns brand air detection and heart-lung systems to detect gross air bubbles in the line during extracorporeal procedures.
Terumo Cardiovascular Systems
Class I - Dangerous
Internal testing at the supplier, revealed that a crimped wire was placed into an air bubble detector (ABD) sensor connector backwards, preventing the crimped wire from locking into the mating wire connector. This intermittent connection may result in false air bubble alarms.
Class I - Dangerous
As a result of the release of new software version to CareLink Personal website, the IOS app for the Continuous Monitoring Glucose system stopped automatically uploading data to the website.
Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 3/8x3/32, Catalog Number 5773 - Product Usage: intended for use with Terumo and Sarns brand air detection and heart-lung systems to detect gross air bubbles in the line during extracorporeal procedures.
Terumo Cardiovascular Systems
Class I - Dangerous
Internal testing at the supplier, revealed that a crimped wire was placed into an air bubble detector (ABD) sensor connector backwards, preventing the crimped wire from locking into the mating wire connector. This intermittent connection may result in false air bubble alarms.
Class I - Dangerous
Incorrect expiration date included in test kit labeling and/or in Substrate component label.