🏥 Medical Devices Class I - Dangerous
Three complaints describing TruSystem tables unexpectedly descending approximately 20 centimeters.
All Recalls
95,089 total recalls in our database
Zenostar MT Color Impulse orange, art. no. 681168. Product Usage: For coloring dental porcelain
Ivoclar Vivadent
🏥 Medical Devices Class I - Dangerous
The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.
🏥 Medical Devices Class I - Dangerous
Three complaints describing TruSystem tables unexpectedly descending approximately 20 centimeters.
🏥 Medical Devices Class I - Dangerous
The infant performance test did not meet the test specification for the Infant Head Uniformity test with High Resolution. As a result, when the user performs High Resolution head scans, the reconstructed images may exhibit degraded image quality manifested as non-uniformity of the image, CT number shift greater than 5 Hounsfield units, and reduction in gray/white matter differentiation. The issue is most sever in the High Resolution mode, and the factory reference pediatric scan protocols are set to High Resolution default. Adults head scans have a factory reference protocol that defaults to standard resolution which doesn't experience the issue.
Zenostar MT Color D3 60ml, art. no. 681064. Product Usage: For coloring dental porcelain
Ivoclar Vivadent
🏥 Medical Devices Class I - Dangerous
The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.
🏥 Medical Devices Class I - Dangerous
Siemens became aware of a potential issue with the patient table for Ysio Max and Multix Fusion systems. There is an unlikely risk that an internal part of the table may detach causing the table top to tilt to the left side which could result in an injury to a patient on the table.
🏥 Medical Devices Class I - Dangerous
FDA inspection found that customers who had received devices with promotional material with outside use indications were not notified when labeling was revised to remove these indications.
🏥 Medical Devices Class I - Dangerous
Three complaints describing TruSystem tables unexpectedly descending approximately 20 centimeters.
Zenostar MT Color C2 60ml art. no. 681060. Product Usage: For coloring dental porcelain
Ivoclar Vivadent
🏥 Medical Devices Class I - Dangerous
The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.
🏥 Medical Devices Class I - Dangerous
During final sampling inspection, one of the lots was discovered with a total incomplete packaging seal of the sterile product.
Toshiba America Medical Systems, Inc . Aquilion RXL TSX-101 A/R, U CT Scanner Diagnostic imaging systems indicated to acquire and display cross sectional volumes of the whole body, to include the head.
Toshiba American Medical Systems
🏥 Medical Devices Class I - Dangerous
It has been found that if the scan range extends beyond the maximum Field of View (FOV), a reconstruction operation error may occur. As a result, scanning may be interrupted and rebooting of the system may be necessary. Please note that this issue has not occurred in the U.S.
Arthrex Suture Washer
Arthrex
🏥 Medical Devices Class I - Dangerous
The device was assembled incorrectly. Suture and washer were not assembled; components were placed loose in the package.
🏥 Medical Devices Class I - Dangerous
During final sampling inspection, one of the lots was discovered with a total incomplete packaging seal of the sterile product.
FDA inspection found that customers who had received devices with promotional material with outside use indications were not notified when labeling was revised to remove these indications.
Merit Inflation Syringe Kit. Catalog Number KOS-02857
Merit Medical Systems
🏥 Medical Devices Class I - Dangerous
Merit Medical Systems, Inc. announces a voluntary field action for Merit Inflation Syring Kit due to unit labels missing required device labeling information.
Walrus Arterial Embolectomy Catheter The arterial embolectomy catheter is intended for use in removing arterial emboli.
Arrow International
🏥 Medical Devices Class I - Dangerous
Arrow is recalling due to incorrect labeling of products.
Zenostar MT Color A3.5 60ml, art. no. 681053. Product Usage: For coloring dental porcelain
Ivoclar Vivadent
🏥 Medical Devices Class I - Dangerous
The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.
🏥 Medical Devices Class I - Dangerous
Three complaints describing TruSystem tables unexpectedly descending approximately 20 centimeters.
🏥 Medical Devices Class I - Dangerous
The infant performance test did not meet the test specification for the Infant Head Uniformity test with High Resolution. As a result, when the user performs High Resolution head scans, the reconstructed images may exhibit degraded image quality manifested as non-uniformity of the image, CT number shift greater than 5 Hounsfield units, and reduction in gray/white matter differentiation. The issue is most sever in the High Resolution mode, and the factory reference pediatric scan protocols are set to High Resolution default. Adults head scans have a factory reference protocol that defaults to standard resolution which doesn't experience the issue.
🏥 Medical Devices Class I - Dangerous
Panoramic Corporation is performing a voluntary Medical Device Correction on certain PC-1000 X-ray systems due to the potential for a safety nut to be ineffective, which could result in blunt force trauma that may impact the head, neck or shoulders.