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Delta Med SpA Via Guido Rossa 20 Viadana Italy: DELTAVEN FASTFLASH, Safety I.V. Catheter in Pur with clos...

Problems related to the sterilization of the medical devices; possible missing sterility of the medical device

FDAJun 21, 2021Nationwide• Delta Med SpA Via Guido Rossa 20 Viadana Italy

Delta Med SpA Via Guido Rossa 20 Viadana Italy: NEO DELTA SELFSAFE PUR T, I.V. Catheter: a) REF 3738522 b...

Problems related to the sterilization of the medical devices; possible missing sterility of the medical device

FDAJun 21, 2021Nationwide• Delta Med SpA Via Guido Rossa 20 Viadana Italy

Delta Med SpA Via Guido Rossa 20 Viadana Italy: NEO DELTA Self Safe, I.V. Catheter REF 3738222

Problems related to the sterilization of the medical devices; possible missing sterility of the medical device

FDAJun 21, 2021Nationwide• Delta Med SpA Via Guido Rossa 20 Viadana Italy

WOM World of Medicine AG Salzufer 8 Berlin Germany: Covidien HysteroLux Fluid Management System Control Unit,...

When the display of inflow volume to the uterus reaches 32450 ml, the fluid management system control unit display will freeze because the internal software calculation threshold is reached. The outflow measurement will continue, and so the deficit accumulated up to this point will start counting backwards to 0 ml. There is a risk of distention fluid reaching the soft tissue circulatory system.

FDAJun 18, 2021Nationwide• WOM World of Medicine AG Salzufer 8 Berlin Germany

Respironics California, LLC: Philips Respironics V60 Plus Ventilator with Software Ver...

It has been identified that ventilators equipped with High Flow Therapy (Software Versions 3.00 and 3.10), that includes a designed safety mechanism that limits the amount of pressure that can be delivered to a patient, in situations where the system pressure reaches the maximum limit and sounds the "Cannot Reach Target Flow" alarm , the system will reduce pressure and simultaneously decreasing the flow rate to a level below what was set by the clinicians. If the reason for the increase in pressure is not resolved, the ventilator will continue to provide the lower flow rate, which result in patients experiencing oxygen desaturation which can be characterized as moderate or severe hypoxemia.

FDAJun 18, 2021Nationwide• Respironics California, LLC

Respironics California, LLC: Philips Respironics V60 Ventilator with Software Versions...

It has been identified that ventilators equipped with High Flow Therapy (Software Versions 3.00 and 3.10), that includes a designed safety mechanism that limits the amount of pressure that can be delivered to a patient, in situations where the system pressure reaches the maximum limit and sounds the "Cannot Reach Target Flow" alarm , the system will reduce pressure and simultaneously decreasing the flow rate to a level below what was set by the clinicians. If the reason for the increase in pressure is not resolved, the ventilator will continue to provide the lower flow rate, which result in patients experiencing oxygen desaturation which can be characterized as moderate or severe hypoxemia.

FDAJun 18, 2021Nationwide• Respironics California, LLC

Medicalplastic S.R.L. Via Saverio Mercadante: Ilizarov Wire Tensioner, Model 71070341, UDI (10)08033201...

Medicalplastic s.r.l. is conducting a voluntary field action to remove a group of Ilizarov Wire Tensioners due to a manufacturing error. An internal washer of the Ilizarov Wire Tensioner has been made in a wrong plastic material that could wear and break during the sterilization process in autoclave. Consequently this could cause malfunctioning of the tensioner.

FDAJun 17, 2021TN• Medicalplastic S.R.L. Via Saverio Mercadante

Ion Beam Applications S.A. Chemin Du Cyclotron 3 Louvain-la-neuve Belgium: Proteus 235- designed to produce and deliver a proton bea...

Users may be misled by the popup message displayed by the Proton Therapy System when the Oncology Information System appears disconnected, may cause mistreatment

FDAJun 14, 2021Nationwide• Ion Beam Applications S.A. Chemin Du Cyclotron 3 Louvain-la-neuve Belgium

Philips Respironics, Inc.: A-Series BiPAP A 40, A-Series BiPAP A30 Continuous Ventil...

The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the devices air pathway and be ingested or inhaled by the user, and the PE-PUR foam may off-gas certain chemicals.

FDAJun 14, 2021Nationwide• Philips Respironics, Inc.

Philips Respironics, Inc.: A-Series BiPAP Hybrid A30 (not marketed in US), A-Series ...

The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the devices air pathway and be ingested or inhaled by the user, and the PE-PUR foam may off-gas certain chemicals.

FDAJun 14, 2021Nationwide• Philips Respironics, Inc.

Arthrex, Inc.: Suture Anchor, BioComposite SwiveLock C, 5.5 mm x 19.1 mm...

Not properly sterilized, because the outer pouch seal on the Tyvek header was sealed closely to the foil pouch.

FDAJun 14, 2021Nationwide• Arthrex, Inc.

Philips Respironics, Inc.: Philips Respironics E30 with Humidifier, Continuous Venti...

The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the device s the air pathway and be ingested or inhaled by the user, and the PE-PUR foam may off-gas certain chemicals.

FDAJun 14, 2021Nationwide• Philips Respironics, Inc.

GE Healthcare, LLC: Revolution EVO, Optima CT660, Optima CT680 CT Systems.

Improperly loaded software options may result in additional X -ray radiation exposure to the patient.

FDAJun 14, 2021Nationwide• GE Healthcare, LLC

Philips Respironics, Inc.: Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Co...

The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the devices air pathway and be ingested or inhaled by the user, and the PE-PUR foam may off-gas certain chemicals.

FDAJun 14, 2021Nationwide• Philips Respironics, Inc.

Philips Respironics, Inc.: SystemOne (Q-Series), DreamStation, DreamStation Go, Dor...

The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the device s the air pathway and be ingested or inhaled by the user, and the PE-PUR foam may off-gas certain chemicals.

FDAJun 14, 2021Nationwide• Philips Respironics, Inc.

Philips Respironics, Inc.: DreamStation ASV, DreamStation ST, AVAPS, SystemOne ASV4,...

The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the device s the air pathway and be ingested or inhaled by the user, and the PE-PUR foam may off-gas certain chemicals.

FDAJun 14, 2021Nationwide• Philips Respironics, Inc.

Medtronic Heart Valves Division: CoreValve Evolut PRO Delivery Catheter System, REF: ENVPR...

Due to reports of actuator separation for various delivery catheter systems. Affected products were manufactured before July 11, 2020.

FDAJun 11, 2021AL, AK, AZ +45 more• Medtronic Heart Valves Division

Medtronic Heart Valves Division: CoreValve Evolut R Delivery Catheter System, REF: ENVEOR-...

Due to reports of actuator separation for various delivery catheter systems. Affected products were manufactured before July 11, 2020.

FDAJun 11, 2021AL, AK, AZ +45 more• Medtronic Heart Valves Division

Medtronic Heart Valves Division: CoreValve Evolut PRO PLUS Delivery Catheter System, REF: ...

Due to reports of actuator separation for various delivery catheter systems. Affected products were manufactured before July 11, 2020.

FDAJun 11, 2021AL, AK, AZ +45 more• Medtronic Heart Valves Division

Abbott Laboratories: REF 8L92-22, Abbott Activated Alanine aminotransferase, f...

There is a potential for >10% under-recovery on Activated Alanine Aminotransferase (A-ALT) samples greater than 1,200 U/L. In addition there is a potential for a >10% shift in patient results with samples containing bilirubin concentrations greater that 31 mg/dL. This could lead to incorrect patient results

FDAJun 10, 2021Nationwide• Abbott Laboratories

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