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Showing 6341–6360 of 8389 results

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BiPAP A40 (Philips) – VOC Off-Gassing Risk (2022)

Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.

FDAAug 26, 2022AL, AK, AZ +39 more• Philips Respironics, Inc.

BiPAP V30 Auto (Philips) – VOC Off-Gassing Risk (2022)

Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.

FDAAug 26, 2022AL, AK, AZ +39 more• Philips Respironics, Inc.

OmniLab Advanced+ (Philips) – VOC Off-Gassing Risk (2022)

Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.

High

FDAAug 26, 2022AL, AK, AZ +39 more• Philips Respironics, Inc.

BiPAP A30 (Philips) – VOC Off-Gassing Risk (2022)

Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.

FDAAug 26, 2022AL, AK, AZ +39 more• Philips Respironics, Inc.

G7 Acetabular System (Zimmer) – Packaging Integrity Risk (2022)

The outer sterile package cavity has a corner wall thickness that is below the specification. The thin corner wall could potentially crack during transit. Potential risks include non-clinically or clinically significant extension of surgery, or infection leading to surgical intervention.

FDAAug 25, 2022Nationwide• Zimmer, Inc.

Dimension Vista HDLC Test (Siemens) – Result Accuracy Problem (2022)

Dimension Vista High Density Lipoprotein Cholesterol (HDLC) Potential for Erroneous Result. If an HDLC QC or patient result is obtained without an Abnormal Reaction [E145]: flag, a falsely depressed or elevated result ranging from -90% to 133% may be observed.

FDAAug 24, 2022Nationwide• Siemens Healthcare Diagnostics, Inc.

Tibial Bearing MK4 (Howmedica) – Component Compatibility Issue (2022)

A MK4 Tibial Bearing was supplied with the intention to mate with the Tibial Metal Casing in-situ. However, the device in-situ was a MK3 Tibial Metal Casing. The supplied MK4 tibial bearing was not exchangeable for the MK3 tibial bearing. The surgeon needed to complete the surgery by re-assembling and re-inserting the extracted MK3 tibial bearing.

FDAAug 24, 2022IN, NY• Howmedica Osteonics Corp.

Multi-Site Attachment Ring (SenTec) – Weak Skin Adhesion (2022)

Weak skin adhesion.

FDAAug 22, 2022Nationwide• SenTec AG Ringstrasse 39 Therwil Switzerland

Puritan Bennett 560 Ventilator (Covidien) – Gas Supply Failure (2022)

Medtronic has confirmed six reports from customers outside the US where the ventilator became inoperable due to loss of gas supply caused by manufacturing error of specific turbine components.

FDAAug 19, 2022IN, WA• Covidien Llc

Alinity SARS-CoV-2 Control Kit (Abbott) – Internal Control Failure (2022)

Reports received of an increase of message code 9186 (internal control failed) when using the kit.

FDAAug 19, 2022AZ, CA, CT +21 more• Abbott Molecular, Inc.

Dimension Magnesium Test (Siemens) – Quality Control Problem (2022)

Dimension Magnesium (MG) Flex reagent cartridge lots may exhibit imprecision for Quality Control (QC) and produce Abnormal Reaction flags. The issue is not always detected by QC and erroneous results may be produced in the absence of an Abnormal Reaction flag. Based on customer data, imprecision leading to erroneous, unflagged patient results with a bias of -15 to -59% may occur

FDAAug 17, 2022Nationwide• Siemens Healthcare Diagnostics, Inc.

Bentson Plus Wire Guide (Cook) – Packaging Seal Breach (2022)

Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.

FDAAug 16, 2022Nationwide• Cook Incorporated

Bentson Distal Flexibility Guide (Cook) – Packaging Seal Breach (2022)

Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.

FDAAug 16, 2022Nationwide• Cook Incorporated

Heavy Flexible Wire Guide (Cook) – Packaging Seal Breach (2022)

Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.

FDAAug 16, 2022Nationwide• Cook Incorporated

Cope Mandril Steel Guide (Cook) – Packaging Seal Breach (2022)

Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.

FDAAug 16, 2022Nationwide• Cook Incorporated

Roadrunner PC Hydrophilic Guide (Cook) – Packaging Seal Breach (2022)

Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.

FDAAug 16, 2022Nationwide• Cook Incorporated

Roadrunner PC Wire Guide (Cook) – Packaging Seal Breach (2022)

Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.

FDAAug 16, 2022Nationwide• Cook Incorporated

Bentson Wire Guide (Cook) – Packaging Seal Breach (2022)

Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.

FDAAug 16, 2022Nationwide• Cook Incorporated

Vinyl Connecting Tube (Cook) – Packaging Seal Breach (2022)

Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.

FDAAug 16, 2022Nationwide• Cook Incorporated

Roadrunner PC Firm Wire Guide (Cook) – Packaging Seal Breach (2022)

Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.

FDAAug 16, 2022Nationwide• Cook Incorporated

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