Other Medical Devices

There is a potential for the sterility of the device to be compromised.

Medical convenience kits containing Medtronic Aortic Root Cannula are being recalled due to the potential excess material in the male lures on the aortic cannula.

DNA Labeling Kit for use in sample labeling to be hybridized to oligonucleotide microarrays has a component, Human Reference DNA Female aliquot, affected by a mosaic aberration that may result in Chromosome 12 baseline shift, which may lead to false positive/negative results, resulting in diagnosis delay, and may lead to delayed treatment of a treatable genetic disorder.

Specific Medline Kits were manufactured using Intubation ORAL/NASAL Endotracheal Tubes which were subsequently recalled by Smiths Medical.

There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.

There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.

There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.

There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.

There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.

The head of the phoropter head could come loose and potentially detach due to a default in the assembly.

There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.

Identified curing issues with the silicone during the needles manufacturing process.

Identified curing issues with the silicone during the needles manufacturing process.

The potential for cracks forming in the breathing circuit hose.

There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.

There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.

There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-IW (PACS-IW), Centricity Radiology RA600 (RA600), & Centricity Cardiology CA1000 (CA1000) where the service login credentials are able to be identified which could allow a malicious actor with these credentials to access the system and potentially manipulate patient data.

There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.

The head of the phoropter head could come loose and potentially detach due to a default in the assembly.

Single-use battery-powered blood pressure monitor, for use on neonates and infants, due to vibratory noise, may not adequately detect changes in blood pressure per specification. Containment actions: 1) Ventilator lines not to touch the isolette (e.g. mattress, side rails, pillow) or patient, 2) Move affected monitor to patient's foot.