RaySearch Laboratories issued an urgent field safety notice in Europe to warn on an issue with the dose calculation for the Siemens (NYSE:SI) virtual wedge in several of RaySearch’s RayStation treatment planning systems. The affected RayStation models listed in the safety notice out of Germany included RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 4.9 (RayPlan 1), […]
Teleflex warns on Arrow multi-lumen catheter
Teleflex (NYSE:TFX) this week initiated a voluntary field safety corrective action in Europe for its Arrow subsidiary’s multiple-lumen catheter. In a field safety notice dated March 16, Teleflex announced that Arrow is voluntarily recalling the catheter due to a potential sterility issue. Get the full story at our sister site, Medical Tubing & Extrusion
BD subsidiary CME recalls BodyGuard sets after reports of under-infusion
The FDA today said it is designating a recall of CME America BodyGuard microset infusion sets as Class I — it’s most serious level — after complaints of under-infusion related to the sets. CME America, a subsidiary of Becton Dickinson (NYSE:BDX), initiated the U.S. recall of the sets (catalog number A120-003XYVA) on Sept. 6, 2019, recalling […]
NuVasive recalls scoliosis treatment devices
NuVasive (NSDQ:NUVA) issued an urgent field safety notice to warn users of an issue with the separation of a certain component in its Magec system model X rods. According to the safety notice, post-implant separation of an actuator end cap component was observed in the rods. Data from post-market surveillance revealed that the end cap separation […]
Zimmer Biomet warns on some StageOne bone spacer molds
Zimmer Biomet (NYSE:ZBH) issued an urgent field safety notice in Europe to warn on certain StageOne and StageOne Select bone cement spacer molds due to potentially insufficient cleaning and monitoring. According to the notice, certain devices may have undergone an insufficient cleaning process or were subject to potentially inadequate process monitoring for cleaning parameters. More than […]
Medtronic recall of HeartWare HVAD system battery charger is Class I
The FDA has labeled a Medtronic (NYSE:MDT) HeartWare HVAD system battery charger as Class I — it’s most serious level. A notice out March 9 from the FDA said that the Fridley, Minn.-based medtech giant recalled 5,489 total battery charger devices due to the potential for an HVAD system user to mistakenly insert the charger’s AC […]
Smiths Medical warns on LogiCal blood sampling system sets
Smiths Medical issued an urgent field safety notice to warn of corrective action for its LogiCal 5 ml closed blood sampling system sets and HemoDraw Plus closed blood sampling sets with the LogiCal pressure monitoring system. The company said in the notice out of Germany that it became aware that customers using the LogiCal and […]
BD recalls hundreds of thousands of Alaris pumps due to multiple issues
The FDA today warned on a Class I recall of Becton Dickinson (NYSE:BDX) Alaris system infusion pumps due to multiple system errors, software errors, and use-related errors. All lots of five different models of the Alaris system were included in the recall that Becton Dickinson initiated on Feb. 4. In total, the company recalled 774,000 devices […]
Integra warns on NeuraGen Nerve Guide
Integra LifeSciences (NSDQ:IART) issued an urgent field safety notice to warn of an issue with the 7 mm NeuraGen Nerve Guide due to one specific lot of parts that failed to meet release criteria. The NeuraGen Nerve Guide, part number PNG720, had one lot released that was out of specification for a finished goods release test. […]
Medtronic issues urgent field safety notice for some Pipeline Flex embolization devices
Medtronic (NYSE:MDT) issued an urgent field safety notice to warn on specific production lots of its Pipeline Flex embolization devices due to the potential for device fracture. The medtech giant initiated verbal communication about the issue last month after identifying the potential for device fracture at the distal section during use, due to a weakened bond […]
Advanced Bionics recalls certain cochlear implants due to hearing degradation
Advanced Bionics announced a voluntary recall of the initial version of its HiRes Ultra and Ultra 3D cochlear implant devices due to a decrease in performance experienced by some recipients. The company has experienced recent increases in Ultra device explants related to low impedances and reports of hearing performance degradation. As of Feb. 11, in […]
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