Potential for breach of Tyvek seals.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
37,779 Total Recalls
Class I - Dangerous
Potential for breach of Tyvek seals.
ELEOS COLLAR STEM, CEMENTED, FLUTED, 13MM X 120MM. Model Number: HC-13120-03M. Component of Limb Salvage System with BioGrip.
Onkos Surgical
Class I - Dangerous
Mislabeling of 13mm Modular Segmental Stem package (HC-13120-03M) which included an implant that was 15mm in diameter (HC-15120-03M) instead of being 13mm as stated on the package. The corresponding 15mm cemented stems were mislabeled as size 13mm cemented stems.
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.
Imaging system data may be displayed with an incorrect orientation (sidedness) where the patient side is not correct (left, right, superior, inferior, anterior or posterior). This may lead to an inaccurate measurements.
Product Name: Evolution Upgrade 3.0T; Model Numbers: (1) 782117, (2) 782143;
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, 10.0Fr, Reference Part Number(RPN) REF RCFW-10.0-0-38-30-RB, Order Number (GPN) REF G08686,
Cook Incorporated
Class I - Dangerous
Cook Medical identified that devices from the affected device lots may contain the incorrectly sized introducer sheath.
Product Name: Ingenia 3.0T CX; Model Number: 781271;
Philips North America
Class I - Dangerous
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Centerline Biomedical IOPS Guidewire 2, REF ATW-2; Sensorized wire used to navigate through vasculature to facilitate placement of a catheter
Centerline Biomedical
Class I - Dangerous
Centerline Biomedical has determined that the coating on the guidewires for lot 2404-2005 may delaminate during use of the guidewire.
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.
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.