🏥 Medical Devices • 6,627 recalls
Ventana Medical Systems
Increased reports of leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers (part of the iView, ultraView and OptiView detection kits, as well as CINtec PLUS Cytology Kit) and with Hematoxylin II.
The BC Thrombin Reagent kit lot 46751 (contains Thrombin Reagent lot 517468) and kit lot 47184 (contains Thrombin Reagent lot 517469) produce unexpected prolonged Thrombin Time (TT) results for expected normal samples, and may recover above the upper limit of normal (< 21 sec.) as stated within the IFU (Instruction For Use).
Ventana Medical Systems
Increased reports of leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers (part of the iView, ultraView and OptiView detection kits, as well as CINtec PLUS Cytology Kit) and with Hematoxylin II.
Ventana Medical Systems
Increased reports of leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers (part of the iView, ultraView and OptiView detection kits, as well as CINtec PLUS Cytology Kit) and with Hematoxylin II.
VITROS Performance Verifier II (PVII) Lot K4852 does not meet long term stability requirements for the AST Analyte (only) when the product is stored refrigerated for up to 6 months.
Siemens has identified an issue when scanning the 20 barcode for the Master Curve Card (MCC) with ADVIA Centaur systems T3 kit lots ending in 198 on the ADVIA Centaur XPT system.
The foot control used on the OAKWORKS¿ Inc., CFPM300, CFPM301, CFPM400, CFPM401, CFPMB301, CFUR301, CFUR401 and CFLU401 Imaging Tables can become lodged under the base or under the column of the table.
Hitachi Medical Systems America
The ultrasound probe may not have adequate protection against electrical shock hazards.
The tucking depth feature of this catheter introducer is marginally outside the upper specification.
Ventana Medical Systems
Increased reports of leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers (part of the iView, ultraView and OptiView detection kits, as well as CINtec PLUS Cytology Kit) and with Hematoxylin II.
Stryker Communications
The mounts on the monitor may have an insufficient (missing or incomplete) weld.
A system component overheated causing melting of the connector and emission of smoke through the systems loudspeaker opening.
Ventana Medical Systems
Increased reports of leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers (part of the iView, ultraView and OptiView detection kits, as well as CINtec PLUS Cytology Kit) and with Hematoxylin II.
Ventana Medical Systems
Increased reports of leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers (part of the iView, ultraView and OptiView detection kits, as well as CINtec PLUS Cytology Kit) and with Hematoxylin II.
Ventana Medical Systems
Increased reports of leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers (part of the iView, ultraView and OptiView detection kits, as well as CINtec PLUS Cytology Kit) and with Hematoxylin II.
The duodenoscopes are being recalled in order to replace the forceps elevator mechanism, the O-rings, and the distal end covering to be consistent with the updated design as well as provide an updated periodic inspection as part of the Operation Manual in order to mitigate the potential risk of infection in flexible endoscopy.
Inform users of correct placement of the disposable adhesive pad on the QCPR meter and inform users of injuries associated with proper performance of CPR. As required by Consent Decree of Permanent Injunction No. 1:17-cv-11955-DJC, entered October 31, 2017 between United States of America and Philips North America
Reports of gastric or esophageal perforation occurring in procedures where the GastriSail" Gastric Positioning device has been used.
Inform users of correct placement of the disposable adhesive pad on the QCPR meter and inform users of injuries associated with proper performance of CPR. As required by Consent Decree of Permanent Injunction No. 1:17-cv-11955-DJC, entered October 31, 2017 between United States of America and Philips North America
Due to a time conversion error, data uploaded from the iPro(TM)2 recorder to the CareLink iPro software using the new CareLink iPro Uploader feature may result in incorrect reports. This pertains only to reports generated between September 23, 2017 and September 27, 2017 that used the new CareLink iPro Uploader feature.