Rappels de dispositifs médicaux de la FDA
Derniers rappels, corrections et retraits de dispositifs médicaux publiés par la FDA. Restez informé des problèmes de sécurité.
Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressur…
A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.
Voir le rappel de la FDA →Carescape Central Station CSCS V3 MAS800 Desktop Part Number 5867474-04, 5867474-13 Product cod…
Device may not resume patient monitoring for at least 3 minutes following system restart. Issue can lead to potential delay in recognition of clinical…
Voir le rappel de la FDA →HEALON EndoCoat PRO, REF: 10300012 (US/CAN) HEALON DUET PRO II, REF: 10300016 (US/CAN) HEALON E…
Surgical instructions sent for viscoelastic products used during ophthalmic viscosurgical cataract procedures including in part: If resistance is enco…
Voir le rappel de la FDA →CombiSet Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer Protectors; Model N…
Communication to recommend reviewing the IFU and ensuring that all treatment preparation and handling steps are performed as instructed.
Voir le rappel de la FDA →StatStrip Glucose and B- Ketone meter. Model No: 63910. Glucose test system.
A software synchronization/timing issue in the barcode scanning and patient data processing component that causes the device to intermittently retain …
Voir le rappel de la FDA →Oncology sets with drip chambers
Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyviny…
Voir le rappel de la FDA →Ingenia Elition S and Ingenia Elition X; Model Numbers (REF): 1. 781357(S), 2. 782106(S), 3. 782137…
A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstr…
Voir le rappel de la FDA →Aisys CS2, Datex-Ohmeda anesthesia system, Part Number 1011-9055-000
Anesthesia Delivery Systems containing certain electronic gas mixer assemblies can automatically transition to Alternate O2 control. In Alternate O2 c…
Voir le rappel de la FDA →nGenuity Patient Monitor with Capnography (ETCO2) CAT 8100E1-ST-US, CAT 8100E1-US, CAT 8100EP1, C…
Complaint trend where "Checkline Error" alarm presents at device setup, rendering the CO2 monitoring function inoperable. May result in procedure dela…
Voir le rappel de la FDA →Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressur…
A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.
Voir le rappel de la FDA →