Category hub
High activity category
This category has a significant number of recalls. Check it regularly if you own products in this area.
Abiomed recalled two units of the Impella 5.5 with SmartAssist on December 4, 2025. The devices were packaged in incorrect outer cartons, posing a potential hazard. Patients and healthcare providers must stop using the devices immediately.
AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Position Warning" label.
Inflation device handle may detach from the syringe during procedure.
Due to probe bags that may have a compromised or incomplete sterile pouch seal.
Inflation device handle may detach from the syringe during procedure.
Stents may be impacted by a Nitinol anomaly which causes a reduced stent diameter when deployed and corresponding reduced radial force. Issue may result in stent migration.
Inflation device handle may detach from the syringe during procedure.
AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Position Warning" label.
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).
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).
Philips North America recalled six MR systems on December 3, 2025. The recall affects devices with software versions R11.1 and R12.1 due to potential stiffness value errors. Healthcare providers must stop using the affected units immediately.
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
Philips North America recalled three MR systems on December 3, 2025. The recall affects models with software versions R11.1 and R12.1 due to potential stiffness value errors. Healthcare providers and patients must stop using these devices immediately.
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).
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).
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).