Product Name: Ingenia 1.5T CX; Model Number: 781262;
Philips North America
Class I - Dangerous
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
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Other Medical Devices
🏥 Medical Devices • 15,809 recalls
Product Name: MR 7700; Model Numbers: (1) 782120, (2) 782153;
Philips North America
Class I - Dangerous
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Check=Flo Performer Introducer, 14.0Fr, Reference Part Number(RPN) REF RCFW-14.0-0-38-30-RB, Order Number (GPN) REF G08957,
Cook Incorporated
Class I - Dangerous
Cook Medical identified that devices from the affected device lots may contain the incorrectly sized introducer sheath.
Class I - Dangerous
Due to incorrect the battery charger being packaged and distributed. Product labeling does not match the intended product as specified.
Class I - Dangerous
Due to customer complaints, there is a potential for users to be unable to or find it difficult to remove the plastic plugs in order to inflate the gastric and/or esophageal balloons.
META-TAN LAG/COMPRESSION SCREW KIT 90MM/85MM, REF: 71642690
Smith & Nephew
Class I - Dangerous
Integrated Lag/Compression Screw Kit has a compression screw with hexagon socket that may be undersized, which causes the screw to be non-functional, which would require replacement with another adequate size screw, and exchange may exceed 30 minutes.
PhenoMATRIX
Copan WASP
Class I - Dangerous
AI-powered bacterial culture plate interpretation and workup software does not have Premarket Approval or pre-market notification (510(k)/de novo), so there is potential risk that the colony count and/or morphology information from images may not accurately reflect actual plate and may lead to inaccurate counts and/or morphology characteristics impacting patient diagnosis and subsequent care.
Product Name: Ingenia Elition X; Model Numbers: (1) 781358, (2) 782107, (3) 782136;
Philips North America
Class I - Dangerous
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Product Name: Ingenia 3.0T; Model Numbers: (1) 781342, (2) 781377, (3) 782103;
Philips North America
Class I - Dangerous
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Product Name: Ingenia 1.5T S; Model Number: 781347;
Philips North America
Class I - Dangerous
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Product Name: SmartPath to dStream for 3.0T; Model Number: 782145
Philips North America
Class I - Dangerous
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Product Name: Ingenia Ambition X; Model Numbers: (1) 781356, (2) 782109, (3) 782138;
Philips North America
Class I - Dangerous
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Product Name: Ingenia Elition S; Model Numbers: (1) 781357, (2) 782106, (3) 782137;
Philips North America
Class I - Dangerous
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Product Name: SmartPath to Ingenia Elition X; Model Numbers: (1) 782118, (2) 782144;
Philips North America
Class I - Dangerous
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Product Name: Ingenia Ambition S; Model Numbers: (1) 781359, (2) 782108, (3) 782139;
Philips North America
Class I - Dangerous
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Endopath Echelon Vascular White Reload for Advanced Placement Tip (35mm, 4 row); Product code VASECR35
Ethicon Endo-Surgery
Class I - Dangerous
Firm has received an increase in reports regarding inadvertent instrument lockout during surgical procedures involving the device. If lockout occurs, the device will momentarily activate but will not cut or staple tissue, and additional steps will be required to open it and remove it from tissue. If user is unable to remove the device from the tissue, potential harms to patient include surgical delay, bleeding/hemorrhage, life threatening hemorrhage/hemorrhagic shock, and conversion to open therapy. Two adverse events received, including one patient death.
Class I - Dangerous
Due to customer complaints, there is a potential for users to be unable to or find it difficult to remove the plastic plugs in order to inflate the gastric and/or esophageal balloons.
Product Name: Evolution Upgrade 1.5T; Model Numbers: (1) 782116, (2) 782148;
Philips North America
Class I - Dangerous
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Product Name: SmartPath to dStream for XR and 3.0T; Model Numbers: (1) 781270, (2) 782113;
Philips North America
Class I - Dangerous
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Product Name: SmartPath to dStream for 1.5T; Model Numbers: (1) 781260, (2) 782112, (3) 782146
Philips North America
Class I - Dangerous
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.