Medical Devices Recalls

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

Unidentified substance of unknown impact was identified on devices during a retrospective evaluation.

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

Unidentified substance of unknown impact was identified on devices during a retrospective evaluation.

Due to complaints, loupe nose pads containing nickel may cause an allergic reaction.

During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS is unable to confirm product sterilization assurance requirements were met.

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

Unexpected PrisMax System alarm T0830: Blood Leak Detected, when no blood leak is present, or difficulty normalizing the Blood Leak Detector (BLD) leading to PrisMax System alarms T1313: BLD Normalize Failed, T0853: Normalization Failed, or T1205: BLD Self-Test Failure

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

Due to complaints, loupe nose pads containing nickel may cause an allergic reaction.

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

Antivirus software was not consistently installed on impacted devices during the implementation process.

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

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Potential for the ESG-410 Electrosurgical Generator to display an error message: "E0662 System Error", followed by either automatic single reboots of the device, or continuous reboot 'loops'.

Resistance and difficulties could occur while closing the retaining clip locking mechanism, which is part of a burr hole cover kit, which is part of a Deep Brain Stimulation (DBS) system, which may lead to procedural delay, or lead-migration-which may require additional surgery.

Due to a classification error in the inventory management system, specific medical devices were shipped to customers that did not have the requisite license to purchase such devices.