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An end user site attempted to perform QC on a single test using multiple QC kits. The QC module was not designed to support testing of multiple QC kits for a single test, and it is required that all QC samples used to validate a test are contained in a…

The pagewriter tc30/50/70 cardiograph device could potentially fail to charge while plugged into the ac power outlet. This is due to a faulty mainboard. based on a supplier analysis, the faulty mainboard was caused by…

Potential for blood leak to occur with the anti-reflux valve upon treatment completion. Recall start date: May 5, 2022.

The Carescape Central Station (CSCS) V2 can shut down due to a potential power supply component failure. This can lead to loss of patient monitoring at the central station. Patient monitoring at the bedside is not affected. Recall start date: May 10,…

During global post market surveillance activities cases have been reported that the sampling pump 6873493 shows a changing characteristic with increasing operating time, which can lead to the deactivation of the gas measurement during operation. The…

The STO2 values may be inaccurately low when using either the fore-sight elite tissue oximeter module (Model HEMFSM10) or the fore-sight elite absolute tissue oximeter monitor (Model 01-06-3000) with the fore-sight elite large sensor (…

A software update for carelink SmartSync™ device managers (SmartSync) will address a telemetry error that may occur with Medtronic Cobalt™ and Crome™ Implantable Cardioverter Defibrillators (ICDs), and Cardiac Resynchronization Therapy Defibrillators (…

The proximal marker on devices from these lots may separate from the device. A dislodged marker may require additional intervention, including unplanned additional coronary intervention, or surgery. To date Abbott has received 5 complaints related to…

During a routine inspection Medtronic noted there was damage to the sterile pouch that contains the In.Pact Admiral Catheters. Upon investigation, there had been a change implemented to one manufacturing line which may cause pouch damage. All batches…

Abbott is notifying physicians of a programmer software anomaly that may be encountered in a very specific circumstance when executing a pacing capture decrement test in-clinic on a gallant, neutrino NXT, or entrant device using a merlin patient care…

Devices from these lots may exhibit leaks and/or a loose connection at the rotating luer assembly or stopcock connection, which could lead to air ingress under vacuum. Analysis indicates an estimated rate of occurrence of air ingress associated with the…

HS1/onsite/home AED pads (pn: m5071a, m5072a) have been observed to experience gel separation from the foam/tin backing when peeled from the yellow plastic liner. The gel may fold onto itself resulting in reduced surface area of gel on the pad, or it may…

Boston Scientific is conducting a removal of specific batches of rotawire drive and wireclip torquer after determining that a small number of pouches containing these products may have a weak seal, which could open during normal shipping and handling and…

Siemens Healthcare Diagnostics Inc. has confirmed customer observations of falsely elevated results when using plasma specimens across the entire analytical measuring range (AMR) with the Atellica IM enhanced estradiol (EE2) assay. Results demonstrate…

Balt Extrusion Sas identified a leak on the pouch near where the stopcock contacts the Tyvek transparent side of the pouch during a stability study. The pouch damage is not likely detectable before the clinical use of the device as the damage on the…