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Showing 5441–5460 of 8393 results

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BioPlex 2200 APLS IgM Pack (Bio-Rad) – Reagent Conjugate Mismatch (2023)

APLS IgM reagent kits were packaged with the incorrect conjugate, which could lead to an increase in false-positive and false-negative results.

FDAFeb 28, 2023Nationwide• Bio-Rad Laboratories, Inc.

Monaco RTP System (Elekta) - Dose Presentation Error (2023)

Re-optimization, after adding contours without forced density outside the external structure, may result in inaccurate dose presentation.

FDAFeb 28, 2023Nationwide• Elekta Inc

Cardiosave Intra-Aortic Balloon Pump (Datascope) - Performance Issue (2023)

There is an issue related to the Safety Disk not meeting a performance requirement that may impact Intra-Aortic Balloon catheter (IAB) displacement volume. This potential failure of an impacted Safety Disk may lead to slightly reduced IAB inflation during therapy or a reduction in the degree of augmentation provided to the patient during therapy.

High

FDAFeb 28, 2023Nationwide• Datascope Corp.

Omega Medical Imaging Monitor Suspension (Omega) - Component Detachment (2023)

An actuator separated from the pivot mechanism on a lower monitor boom system column and became detached and was restrained by the installed safety cable at one location.

FDAFeb 28, 2023Nationwide• Omega Medical Imaging, Inc.

EMPOWR Knee Patella Drill (Unknown) - Incorrect Diameter (2023)

Patella drills are marked with incorrect diameter size of 5.6mm, when they should be 5.4mm. Porous patella overdrills are marked with incorrect diameter size of 5.4 mm, when they should be 5.6 mm. If the incorrect drill is selected during surgery, there is risk of the implant loosening, implant not properly fitting, and/or fractured bone.

FDAFeb 28, 2023AL, CA, HI +5 more

Omnipod 5 Insulin System (Unknown) – App Control Error (2023)

Laceration Risk

An error message was received when using the Omnipod 5 App on compatible smartphones that prevented phone control users from controlling the Omnipod 5 Automated Insulin Delivery System from their Omnipod 5 App which may cause a delay in therapy. To reduce the volume of inquiries Insulet was receiving from customers, an email was sent to all phone control users and the cause of the error message was resolved by reverting to prior certificates on the Insulet cloud to secure communications between the Omnipod 5 App sotware and the Insulet Cloud. This issue was limited to only certain compatible Android smartphones and did not affect the Omnipod 5 Pods or the dedicated locked-down Controller provided by Insulet. All other Omnipod 5 users were still able to manage their insulin with the device without use of the smartphone app and affected users were able to switch to the locked-down control provided to all users when they initiated the device during the time the App was unavailable to them. Further, the Omnipod itself continued to deliver insulin as per its pre-programmed settings so although affected users who did not have the locked-down controller readily available may not have been able to command insulin boluses during this time, they continued to receive basal insulin without interruption. Lastly, users of the Omnipod 5 were advised during training to always have backup supplies ready in the event of a device malfunction which would include alternative means to deliver insulin subcutaneously until the issue is resolved to minimize disruption to their insulin regimen. There were 2,168 complaints received out of 7,838 users with the Android compatible smartphones affected and 9 MDRs were submitted, however, there were no serious injuries reported or reports of erroneous results as the primary issue was a delay in therapy. This defect cannot cause false results that could negatively impact patients.

FDAFeb 28, 2023Nationwide

CoCr Femoral Head (Zimmer) - Compatibility Update (2023)

Update the compatibility matrix as referred to in the Instructions for Use (IFU) for the CoCr Femoral Head XS- removes the compatibility with the Epsilon Durasul Constrained Acetabular Liners from the matrix due to the range of motion in flexion/extension being less than 100 degrees as recommended per an internationally recognized standard (ISO 21535:2009

FDAFeb 27, 2023AL, AZ, CO +6 more• Zimmer, Inc.

FujiFilm FDR AQRO X-ray (FujiFilm) - Arm Breakage (2023)

Arm which holds the tube head in place is susceptible to breaking, if the device breaks it could potentially cause serious harm or injury to the patient and/or user.

FDAFeb 27, 2023Nationwide• FUJIFILM Healthcare Americas Corporation

Tobii Dynavox TD I-110 Speech Device (Tobii) - Battery Placement (2023)

Problem maintaining the stable placement of the battery may come loose from the housing and become damaged.

FDAFeb 24, 2023Nationwide• Tobii Dynavox Llc

Iradimed MRidium Infusion Set (Iradimed) - Adapter Defect (2023)

Certain Iradimed 1057 Syringe Adapter Sets, used with the MRidium MRI infusion pump, have a problem relating to a defective injection molded part which can limit the effectiveness of the syringe venting function which then can result in occlusion.

FDAFeb 24, 2023Nationwide• Iradimed Corporation

Tempus Pro Patient Monitor (Remote Diagnostic) - Safety Issues (2023)

During internal testing, Regulatory Compliance issues were identified regarding the Monitor and Power Supplies for fluid ingress and basic safety issues.

FDAFeb 23, 2023Nationwide• Remote Diagnostic Technologies Ltd. Farnborough Aerospace Centre Aerospace Boulevard Farnborough United Kingdom

Rotatable Clip Device (Olympus) - Procedure Failure (2023)

There have been complaints that the clip did not come out of the tube sheath during the procedure.

FDAFeb 23, 2023Nationwide• Olympus Corporation of the Americas

Caspar Cervical Retractor (Aesculap) - Mislabeling (2023)

Mislabeled: Product is marked with GTIN # 04046955299592 however; the correct GTIN # is 04046955299607.

FDAFeb 23, 2023Nationwide• Aesculap Implant Systems LLC

Automated Peritoneal Dialysis System (Baxter) - Safety Testing (2023)

The electrical safety testing was not properly performed on the impacted devices and additional testing is required

FDAFeb 22, 2023AL, AZ, AR +7 more• Baxter Healthcare Corporation

PCRopsis Reagent (Entopsis) - Label Misleading (2023)

Presence of misleading label statements on the product label.

FDAFeb 21, 2023Nationwide• Entopsis Inc.

Carto Vizigo Guiding Sheath (Biosense Webster) - Incorrect Labeling (2023)

Incorrect labeling; specifically, the product name, lot number and product code on the carton label for Bi-Directional Guiding Sheaths does not match the inner label pouch

FDAFeb 21, 2023Nationwide• Biosense Webster, Inc.

Neodent GM X Titanium Base (Preat) - Movement Issue (2023)

Engaging titanium base contains a dimensional condition that allows vertical movement of the titanium base after the prosthetic screw is torqued to the recommended value, which if undetected and installed on the implant, may lead to abutment/screw fracture, which could result in the abutment/screw/crown being ingested by the patient.

FDAFeb 21, 2023Nationwide• Preat Corp

PCRopsis RVD Reagent (Entopsis) - Label Misleading (2023)

Presence of misleading label statements on the product label.

FDAFeb 21, 2023Nationwide• Entopsis Inc.

BioPlex 2200 Reagent Pack (Bio-Rad) - Result Discrepancy (2023)

Bio-Rad received four customer complaints from 11/30/2022 to 12/21/2022 on BioPlex 2200 Anti-CCP Kit (Lot 301481) stating that results were discrepant while performing lot-to-lot validation against previous lots. Internal testing at Bio-Rad has demonstrated that Lot No. 301481 exhibits a specificity of 94.5% (95% CI 91.8 96.4) whereas the IFU indicates a specificity of 97.8% (95% CI 96.1 98.8%). The reduction in specificity may lead to an increase in the number of false positives.

FDAFeb 21, 2023Nationwide• Bio-Rad Laboratories, Inc.

PCRopsis Support (Entopsis) - Label Misleading (2023)

Presence of misleading label statements on the product label.

FDAFeb 21, 2023Nationwide• Entopsis Inc.

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