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Showing 8441–8460 of 11714 results

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ROi Cataract Kit (ROi) – Surgical Drape Issue (2022)

Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.

FDAOct 20, 2022FL, LA, MO +1 more• ROi CPS LLC

Regard Cataract Kit (ROi CPS) – Surgical Drape Concern (2022)

Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.

FDAOct 20, 2022FL, LA, MO +1 more• ROi CPS LLC

CMV IgM EIA (Bio-Rad) – Diagnostic Test Anomaly (2022)

Due to an unusual increase in the positivity rate with human IgM antibodies to cytomegalovirus (CMV) Enzyme Immunoassay (EIA).

Moderate

FDAOct 19, 2022CA, CO, FL +11 more• Bio-Rad Laboratories, Inc.

Atrium Ocean Chest Drain (Atrium) – Temperature Excursion (2022)

Warehouse experienced temperature excursions in July and August 2021. It was determined that there were no associated harms to patients.

FDAOct 18, 2022Nationwide• Atrium Medical Corporation

Hill-Rom Progressa Bed (Baxter) – Compression Link Failure (2022)

The compression links on impacted Progressa beds, listed in Appendix A, may bend when raising the head section. The labeling for these beds list a maximum patient weight of 500 lbs., however the bending may still occur with a patient weight of less than 500 lbs. depending on the patient 's position on the bed.

FDAOct 18, 2022Nationwide• Baxter Healthcare Corporation

Accelerate PhenoTest BC Kit (Accelerate) – False Positive Risk (2022)

Due improperly formulated and released bulk lot of fluorescence in situ hybridization (FISH) probes resulting in false positive identification results for Staphylococcus aureus and Streptococcus spp.

FDAOct 17, 2022AR, CA, FL +28 more• Accelerate Diagnostics Inc

VS3 Iridium IR Microscope (Visionsense) – Optical Fiber Damage (2022)

Broken Optical fiber cable damage can occur through handling or bending and can lead to loss of functionality and heating/melting of the outer cable surface.

FDAOct 17, 2022Nationwide• Visionsense, Ltd. 20, Ha-Magshimim Petakh Tikva Israel

VS3 Iridium Microscope (Visionsense) – Unspecified Issue (2022)

XXX

FDAOct 17, 2022Nationwide• Visionsense, Ltd. 20, Ha-Magshimim Petakh Tikva Israel

Arrow AutoCAT 2 IABP (Arrow) – Battery Runtime Problem (2022)

There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.

FDAOct 17, 2022Nationwide• ARROW INTERNATIONAL Inc.

Arrow AutoCAT2WAVE IABP (Arrow) – Battery Runtime Concern (2022)

There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.

FDAOct 17, 2022Nationwide• ARROW INTERNATIONAL Inc.

Arrow AutoCAT2 IABP (Arrow) – Battery Runtime Problem (2022)

There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.

FDAOct 17, 2022Nationwide• ARROW INTERNATIONAL Inc.

Arrow AC3 Optimus IABP (Arrow) – Battery Runtime Issue (2022)

There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.

FDAOct 17, 2022Nationwide• ARROW INTERNATIONAL Inc.

Visualase Cooled Laser Applicator (Medtronic) – Sterile Seal Defect (2022)

Due to a defect in the outer pouch sterile seal

FDAOct 14, 2022Nationwide• Medtronic Navigation, Inc.

GentleWave APM Instrument (Sonendo) – Labeling Error (2022)

Procedure Instruments with erroneous unit carton labels.

FDAOct 14, 2022Nationwide• Sonendo Inc

Getinge Operating Table (Getinge) – Backrest Drop Hazard (2022)

The back rest may unintentionally drop suddenly, resulting in adverse health consequences if a patient were to fall on the floor head first and at a steep angle.

FDAOct 14, 2022Nationwide• Getinge Usa Sales Inc

Philips Laser System (Spectranetics) – System Failure Risk (2022)

Laser System may detect Error 106 or Error 108 System Failures that will cause the system to enter non-recoverable safe state. The user will not be able to proceed until the error is cleared. May result in initiation of treatment delay and/or treatment beyond initial scope and/or unable to treat patient.

FDAOct 14, 2022AZ, AR, CA +27 more• Spectranetics Corporation

GentleWave Posterior Instrument (Sonendo) – Labeling Error (2022)

Procedure Instruments with erroneous unit carton labels.

FDAOct 14, 2022Nationwide• Sonendo Inc

VITROS Chemistry Calibrator (Ortho-Clinical) – Calibration Mathematics Issue (2022)

Calibration disk Data Release Version (DRV) 6194 to 6200 contain inappropriate calibration mathematics for VITROS Calibration Kit 9 for calibrating VITROS PHYT Slides, for all lots of slide generation 22 (GEN 22). The erroneous mathematics on the calibration disk prevents the VITROS 250/350 Chemistry System from successfully calibrating, leading to delayed results.

FDAOct 13, 2022Nationwide• Ortho-Clinical Diagnostics, Inc.

EKOS Control Unit (Boston Scientific) – Instructions Mismatch (2022)

Consoles were shipped without an instruction for use (IFU) or with the incorrect IFU.

FDAOct 13, 2022CA, IL, KY +4 more• Boston Scientific Corporation

BD Phoenix PMIC/ID Panel (Becton Dickinson) – Antibiotic Test Issue (2022)

Misformulated minocycline-can cause erroneously increased Minimal Inhibitory Concentration (MIC) values when performing antibiotic susceptibility testing (AST) against minocycline and result in the reporting of false resistance for clinical samples if the initial Quality Control (QC) testing of the panel batch passes, delaying treatment of the patient with the most appropriate antibiotic

FDAOct 13, 2022Nationwide• Becton Dickinson & Co.

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