95,094 total recalls in our database
Philips Medical Systems (Cleveland)
The firm was notified of a software error in which the system may not automatically send all image/data series to remote devices.
The fasteners securing the control panel assembly to the base of the Philips EPIQ Ultrasound System may loosen over time, which could subsequently lead to the detachment of the entire assembly from the ultrasound system.
Philips Medical Systems (Cleveland)
The firm was notified of a software error in which the system may not automatically send all image/data series to remote devices.
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
The Spetzler Claw Tip was packaged with the incorrect Tip Sleeve Assembly. The Tip Sleeve Assembly included in the packaging is the incorrect size. Risk to Health: If the Tip Sleeve Assembly does not fit the Spetzler Claw" Tip, a surgical delay may occur while an alternate Tip Sleeve Assembly is retrieved.
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Philips Medical Systems (Cleveland)
The firm was notified of a software error in which the system may not automatically send all image/data series to remote devices.
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
It was reported that the SYNTHECEL Dura Repair could adhere to various anatomical structures post implantation, which may expose patients to potential risks in the event a surgeon intends to temporarily apply and subsequently remove a SYNTHECEL implant. SYNTHECEL Dura Repair labeling and promotional material are being updated to clarify that SYNTHECEL is intended to remain in place and is not intended to be removed.
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Potential for a component contained in the Implant System to be non-sterile.
Stryker Instruments Div. of Stryker
The affected scanner does not correctly interact with the SC360 software. When docked pre/postoperatively, the affected SurgiCounter scanner may display an error message (code=2). Also, the SurgiCounter scanner software version number is not appropriately displayed in the SC360 application during installation.
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Foreign material in container
Customers may not receive an intended audible alarm or alert if relying on hearing the alarm or alert.
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.