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.
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Other Medical Devices
🏥 Medical Devices • 15,809 recalls
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
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.
Arthrex Suture Washer
Arthrex
Class I - Dangerous
The device was assembled incorrectly. Suture and washer were not assembled; components were placed loose in the package.
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.
Zenostar MT Color A3.5 60ml, art. no. 681053. Product Usage: For coloring dental porcelain
Ivoclar Vivadent
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.
Class I - Dangerous
Three complaints describing TruSystem tables unexpectedly descending approximately 20 centimeters.
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.
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.
Zenostar MT Color Impulse violet, art. no. 681166 Product Usage: For coloring dental porcelain
Ivoclar Vivadent
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.
Zenostar MT Color D4 60ml, art. no. 681065. Product Usage: For coloring dental porcelain
Ivoclar Vivadent
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.
Dimension Vista¿ Calcium (CA) Flex¿ reagent cartridge Device Listing No.: D011443 Batch Number: 16060BB
Siemens Healthcare Diagnostics
Class I - Dangerous
Siemens Healthcare Diagnostics determined that the Dimension Vista Calcium (CA) Flex reagent cartridge lot # 16060BB may produce erroneously low or high results from specific well sets.
Zenostar MT Color Impulse blue, Art. no. 681165 Product Usage: For coloring dental porcelain
Ivoclar Vivadent
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.
Zenostar MT Color Impulse grey, art. no. 681167 Product Usage: For coloring dental porcelain
Ivoclar Vivadent
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.
Zenostar MT Color B3 60ml, art. no. 681057. Product Usage: For coloring dental porcelain
Ivoclar Vivadent
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.
Zenostar MT Color A4 60ml, art. no. 681054. Product Usage: For coloring dental porcelain
Ivoclar Vivadent
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.
Zenostar MT Color Impulse brown, art. no. 681169 Product Usage: For coloring dental porcelain
Ivoclar Vivadent
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.
Zenostar MT Color B1 60ml, art. no. 681055. Product Usage: For coloring dental porcelain
Ivoclar Vivadent
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.
Zenostar MT Color C4 60ml, art. no. 681062. Product Usage: For coloring dental porcelain
Ivoclar Vivadent
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.
Zenostar MT Color D2 60ml, art. no. 681063. Product Usage: For coloring dental porcelain
Ivoclar Vivadent
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.