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ZOOM LATITUDE Programmer (Boston Scientific) – Software Anomalies (2022)

There is potential for unanticipated software anomalies to occur when using the Model 2868 Application loaded on the 3120 ZOOM LATITUTDE programmer when communicating with certain Boston Scientific transvenous defibrillators.

FDAJul 7, 2022Nationwide• Boston Scientific Corporation

T-SPOT.TB Test (Oxford Immunotec) – Temperature Storage Issue (2022)

Due to equipment failure, affected products were stored at temperatures outside the validated range of 2-8 degree C for a period longer than the validated storage time.

FDAJul 7, 2022AL, CA, GA +4 more• OXFORD IMMUNOTEC LTD 143 Park Road Abingdon United Kingdom

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ZOOM LATITUDE Programmer (Boston Scientific) – Software Anomalies (2022)

T-SPOT.TB Test (Oxford Immunotec) – Temperature Storage Issue (2022)

ZOOM LATITUDE Programmer (Boston Scientific) – Software Anomalies (2022)

ShockPulse-SE Lithotripsy Generator (Olympus) – Wiring Noise Problem (2022)

T-Cell Xtend (Oxford Immunotec) – Temperature Storage Issue (2022)

AIM-V Medium (Oxford Immunotec) – Temperature Storage Issue (2022)

ZAP-X Radiosurgery System (Zap Surgical) – Patient Setup Software Issue (2022)

Medicina Oral Tip Syringe 2.5ml (Medicina UK) – Material Specification Problem (2022)

Medicina Oral Tip Syringe 1ml (Medicina UK) – Material Specification Problem (2022)

Medicina ENFit Syringe (Medicina UK) – Material Specification Problem (2022)

Medicina Oral Syringe (Medicina UK) – Material Specification Problem (2022)

Medicina Oral Tip Syringe 0.5ml (Medicina UK) – Material Specification Problem (2022)

Medicina ENFit 5ml Reusable Enteral Syringe (Medicina Uk Ltd) – Unapproved Material (2022)

Da Vinci X/Xi Large Clip Applier (Intuitive Surgical) – Unexpected Motion Risk (2022)

Da Vinci S/Si Large Clip Applier (Intuitive Surgical) – Unexpected Motion Risk (2022)

Echelon -14 Micro Catheter (Micro Therapeutics) – Packaging Water Damage (2022)

Echelon -14, 45 Tip Shape (Micro Therapeutics) – Packaging Water Damage (2022)

CARTO VIZIGO Guiding Sheath (Biosense Webster) – Packaging Water Damage (2022)

ATTUNE Measured Sizing Guide (DePuy Orthopaedics) – Incorrect Spring Material (2022)

Orthex External Fixation Wire (OrthoPediatrics) – Wire Tip Fracture Risk (2022)