All Recalls

There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.

There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.

There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.

There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.

There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.

There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.

There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.

Automated external defibrillators may not fully meet IPx5 water ingress specification. The device may fail to function should water intrusion occur.

There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.

There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.

The terminals on the plug may become loose and overheat.

Internal components of the Protein S ELISA Antigen Kit (Lot: 3-16-5292) were mislabeled. The Protein S Conjugate Solution is labeled as Substrate, and the Substrate is labeled as Protein S conjugate.

There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.

There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.

Any change made to current ultrasound machine software or hardware upgrades, adding or modifying custom fields, or adding a new Ultrasound Machine, must be tested prior to the use in production environment to ensure that ultrasound measurements are crossing over correctly to the AS system

The latest on-site software version may not have been reinstalled at some sites after service activities were performed resulting in images possibly flipped left/right and/or there can be patient data mismatch.

There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.

A potential bias was identified with certain kits compared to the internal standards.

There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.

There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.