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Showing 4541–4560 of 8393 results

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Hemodialysis System (Fresenius) – Tubing Leaching (2023)

Potential PCBA leaching from tubing of hemodialysis machines.

FDASep 6, 2023Nationwide• Fresenius Medical Care Holdings, Inc.

RSP Glenoid Baseplate (Unknown) – Coating Engagement (2023)

Coating hex did not engage with the Straight Mod Hexdriver or with the Hex Head Screw Driver

FDASep 6, 2023AZ, CA, FL +15 more

RX Monaco Analyzer (Randox) – Rerun Setting Failure (2023)

RX Parameter rerun settings (Sample Volume Low/High), and Dilutions used for Auto reruns, not meeting sample re-run conditions when samples are above or below assay range and may result i issues with the re-run feature conditions when incorrectly. Potential to report incorrectly.

Moderate

FDASep 6, 2023Nationwide• Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland

RX Daytona Analyzer (Randox) – Rerun Setting Failure (2023)

RX Parameter rerun settings (Sample Volume Low/High), and Dilutions used for Auto reruns, not meeting sample re-run conditions when samples are above or below assay range and may result i issues with the re-run feature conditions when incorrectly. Potential to report incorrectly.

FDASep 6, 2023Nationwide• Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland

AU/DxC Chemistry Transferrin (Beckman Coulter) – stability claims issue (2023)

The firm has identified that the Transferrin reagent does not meet the Instructions for Use (IFU) reagent on-board stability claims, which may cause control failures and/or erroneous patient samples results. The Complaint handling unit has received a total of 2 safety cases (CASE-2023-02027212 and CASE-2023-02045278) and 99 quality cases with the failure mode attributed to Transferrin reagent (OSR6152 / lot 2573) associated with reagent blank shifts for the Reagent 2 (R2), imprecision, calibration failures, erratic Quality Control (QC) recoveries, and/or erroneous high/low (serum, plasma, urine) patient results. The issue was confirmed through internal testing by Beckman Coulter on June 30, 2023. Reagent Blank shifts for R2, imprecision, calibration failures, erratic Quality Control (QC) recoveries, and/or erroneous high/low (serum, plasma, urine) patient results. The issue was confirmed through internal testing by Beckman Coulter on June 30, 2023.

FDASep 6, 2023Nationwide• Beckman Coulter Biomedical Division Lismeehan, O'Callaghan's Mills County Clare Ireland

RX Modena Clinical Chemistry Analyzer (Randox) – rerun settings issue (2023)

RX Parameter rerun settings (Sample Volume Low/High), and Dilutions used for Auto reruns, not meeting sample re-run conditions when samples are above or below assay range and may result i issues with the re-run feature conditions when incorrectly. Potential to report incorrectly.

FDASep 6, 2023Nationwide• Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland

Hemodialysis System (Fresenius) – Tubing Leaching (2023)

Potential PCBA leaching from tubing of hemodialysis machines.

FDASep 6, 2023Nationwide• Fresenius Medical Care Holdings, Inc.

Meera Mobile Operating Table (Getinge) – Control Unit Problem (2023)

Under certain conditions, an issue might prevent the device from performing as intended. A specific sequence of commands on the control unit activates the traction drive and triggers an unintended driving (autodrive) of max. 7 sec. may result in the following reasonably foreseeable injury or damage to the health of patients and/or users

FDASep 6, 2023Nationwide• Getinge Usa Sales Inc

Venue Go Standard Cart (GE Medical) – Tilt Mechanism Failure (2023)

Some Venue Go Standard Carts can develop an internal failure of the vertical/horizontal tilt adjustment mechanism which can result in the Venue Go system detaching from the cart and falling.

FDASep 6, 2023Nationwide• GE MEDICAL SYSTEMS, ISRAEL LTD. Nativ Haa??or Street no.

Hemodialysis System (Fresenius) – Tubing Leaching (2023)

Potential PCBA leaching from tubing of hemodialysis machines.

FDASep 6, 2023Nationwide• Fresenius Medical Care Holdings, Inc.

BD Pyxis CII Safe (CareFusion) – Formulary Update Issue (2023)

When global edit is used to update multiple formulary properties simultaneously, the following properties: 1) Require Lot Number on Recall, 2) Access Destruction Bin (Witness), 3) Add to Destruction Bin (Count/Empty), 4) CII Safe Stock Out Notice are, without user warning, overwritten to the value NO , which could result in diversion of controlled substances from the automated dispensing cabinet.

FDASep 6, 2023Nationwide• CareFusion 303, Inc.

Hemodialysis System (Fresenius) – Tubing Leaching (2023)

Potential PCBA leaching from tubing of hemodialysis machines.

FDASep 6, 2023Nationwide• Fresenius Medical Care Holdings, Inc.

2008T Hemodialysis System without CDX (Fresenius) – PCBA leaching risk (2023)

Potential PCBA leaching from tubing of hemodialysis machines.

FDASep 6, 2023Nationwide• Fresenius Medical Care Holdings, Inc.

Oasis Dry Suction Water Seal Chest Drain (Atrium) – unauthorized reprocessing (2023)

Product was re-processed and re-sterilized by a third party using packaging configurations and a sterilization process which are not approved by the manufacture and lack validation.

FDASep 5, 2023VA• Atrium Medical Corporation

Zimmer Dermatome Blades (Zimmer Surgical) – skin graft quality issue (2023)

Skin grafts thin and non-uniform when using the affected blades. The issue would be identified at the time of use and may result in the need for additional harvests to adequately cover the area

FDASep 5, 2023Nationwide• Zimmer Surgical Inc

MAZOR X Robotic Guidance System (Unknown) – software update (2023)

Software update

FDASep 5, 2023Nationwide

Segmental Stem Canal Filling 152MM (Onkos Surgical) – Tyvek seal breach (2023)

Potential for breach of Tyvek seals.

FDASep 1, 2023AZ, FL, GA +16 more• Onkos Surgical, Inc.

Robotics Pack (American Contract) – component investigation (2023)

During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252535-02) and Adhesive Dermabond (part number DHVM12) were inadvertently subjected to the ACS sterilization process and exposed to EO and higher temperatures than approved by the component manufacturer. As a result, the components may (1) have a loss/lack of functionality, (2) loss of drug efficacy, if applicable, and (3) have higher than specified EO residuals.

FDASep 1, 2023Nationwide• American Contract Systems, Inc.

Guardian System (Angel Medical) – premature service end (2023)

Device reaching End of Service prematurely.

FDASep 1, 2023Nationwide• Angel Medical Systems, Inc.

Ethos Collar Stem 100MM (Onkos Surgical) – Tyvek seal breach (2023)

Potential for breach of Tyvek seals.

FDASep 1, 2023AZ, FL, GA +16 more• Onkos Surgical, Inc.

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