t:slim X2 Insulin Pump with Interoperable Technology
Reason: A software defect in Version 7.9 of the pump software for Tandem t:slim X2 and Tandem Mobi pumps, when used with Control IQ+ technology, will cause the pump to incorrectly interpol...
Z-1519-2025April 23, 2025San Diego, CA
Micro-X Ltd.
Class IIOngoing
Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV35 Product Description: Rover Mobile X-rays System ("Rover") is a mobile imaging system that incorporates a self-cont...
Reason: Potential for early life x-ray tube failure for mobile x-ray system due to excessive thermal load on the anode.
Z-1579-2025April 23, 2025Tonsley
Tandem Diabetes Care, Inc.
Class IOngoing
Tandem Mobi Insulin Pump with Interoperable Technology
Reason: A software defect in Version 7.9 of the pump software for Tandem t:slim X2 and Tandem Mobi pumps, when used with Control IQ+ technology, will cause the pump to incorrectly interpol...
Reason: Lack of sterility assurance for closed suction catheter systems
Z-1526-2025April 23, 2025Alpharetta, GA
Abbott Diagnostics Scarborough, Inc.
Class IIOngoing
Brand Name: ID NOW Influenza A/B 2 24T Product Name: ID NOW Influenza A/B 2 24T Model/Catalog Number: 427-000 Software Version: N/A Product Description: Influenza A And Influenza B Multiplex Nucleic A...
Reason: the impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.
Reason: Lack of sterility assurance for closed suction catheter systems
Z-1524-2025April 23, 2025Alpharetta, GA
Abbott Diagnostics Scarborough, Inc.
Class IIOngoing
Brand Name: ID NOW RSV 24T Product Name: ID NOW RSV 24T Model/Catalog Number: 435-000 Software Version: N/A Product Description: Respiratory virus panel nucleic acid assay system Component: No
Reason: The impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.
Z-1573-2025April 23, 2025Scarborough, ME
Micro-X Ltd.
Class IIOngoing
Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV71 Product Description: Rover Mobile X-rays System ("Rover") is a mobile imaging system that incorporates a self-cont...
Reason: Potential for early life x-ray tube failure for mobile x-ray system due to excessive thermal load on the anode.
Reason: If "Clear All" selected medications is selected on patient profile, the automated dispensing cabinet may allow dispensing of medication without first requiring the RxVerify Validat...
Reason: Lack of sterility assurance for closed suction catheter systems
Z-1528-2025April 23, 2025Alpharetta, GA
Abbott Diagnostics Scarborough, Inc.
Class IIOngoing
Brand Name: ID NOW COVID-19 2.0 24T Product Name: ID NOW COVID-19 2.0 24T Model/Catalog Number: 192-000 Software Version: N/A Product Description: Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucle...
Reason: the impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.
Z-1574-2025April 23, 2025Scarborough, ME
Abbott Diagnostics Scarborough, Inc.
Class IIOngoing
Brand Name: ID NOW Influenza A/B 2 24T Product Name: ID NOW Influenza A/B 2 24T Model/Catalog Number: 427-000 Software Version: N/A Product Description: Influenza A And Influenza B Multiplex Nucleic A...
Reason: The impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.
Z-1572-2025April 23, 2025Scarborough, ME
ZOLL Circulation, Inc.
Class IOngoing
Brand Name: AutoPulse NXT Resuscitation System Product Name: AutoPulse NXT Platform Model/Catalog Number: Model 200 (Catalog Number: 8700-001070-1) Software Version: Version 2.0.1 Product Descript...
Reason: AutoPulse NXT Resuscitation System may not provide adequate chest compressions or may stop compressions due to code FC1060.
Z-1533-2025April 23, 2025San Jose, CA
Abbott Diagnostics Scarborough, Inc.
Class IIOngoing
Brand Name: ID NOW RSV 24T Product Name: ID NOW RSV 24T Model/Catalog Number: 435-000 Software Version: N/A Product Description: Respiratory virus panel nucleic acid assay system Component: No
Reason: the impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.
Reason: Lack of sterility assurance for closed suction catheter systems
Z-1521-2025April 23, 2025Alpharetta, GA
Tornier S.A.S.
Class IIOngoing
stryker Blueprint Mixed Reality Box Base, Catalog Number MRUE204, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty
Reason: Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system is multifactorial, but in each instance proh...
stryker Blueprint Mixed Reality Instrument Check Block, Catalog Number MRUE203, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty
Reason: Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system is multifactorial, but in each instance proh...
stryker Blueprint Mixed Reality Glenoid Box Lid, Catalog Number MRUE205, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty
Reason: Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system is multifactorial, but in each instance proh...
stryker HoloBlueprint Application, Catalog Number MRUE001; Total Shoulder Arthroplasty
Reason: Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system is multifactorial, but in each instance proh...
BD Pyxis" MedBank" Mini and BD Pyxis" MedBank" Tower, BD Pyxis" MedFlex, BD Pyxis" MedBank" MedPass are automated dispensing cabinets (ADC) intended to securely store and dispense medications to a qua...
Reason: Due to a software bug, automated dispensing cabinet is unable to calculate countback discrepancies during the issue process, which causes incorrect transaction quantity to be recor...