FDA 醫療器材召回
FDA 最新醫療器材召回、修正與移除資訊。即時掌握影響醫療器材的安全問題。
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.
查看 FDA 召回 →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…
查看 FDA 召回 →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…
查看 FDA 召回 →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.
查看 FDA 召回 →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 …
查看 FDA 召回 →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…
查看 FDA 召回 →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…
查看 FDA 召回 →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…
查看 FDA 召回 →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…
查看 FDA 召回 →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.
查看 FDA 召回 →