All Recalls

The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).

Incorrect expiration date

Potential exposure of rodents and rodent activity in the distribution center.

The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).

Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.

It has been discovered that there is a possibility that the fixing screws of the ceiling movement gear in the ceiling suspended arm that are part of the X-ray interventional systems may become loose. As a result, ceiling lateral movement may no longer be possible, abnormal noise may be generated from the suspension system and a sensor error may be displayed

Device user interface (screen) may freeze or become unresponsive to touch when operating in certain non-English language settings. Issue may cause delay or extension while alternate device is located.

The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).

The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).

Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.

Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.

The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).

Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.

The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).

Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.

Undeclared allergens (milk and soy).

Undeclared peanuts.

Undeclared colors FD&C Yellow #5

Potential exposure of rodents and rodent activity in the distribution center.

Potential Listeria Monocytogenes contamination