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SafeControl Handset (Wissner-Bosserhoff) – Reset Mode Concern (2022)

When the handset is disconnected from the power mains, and mains operation is restored, the handset is reset to the preset Resident mode. In this mode, the backrest, legrest, and height adjustment can be moved.

Moderate

FDAJul 11, 2022Nationwide• WISSNER-BOSSERHOFF GMBH Hauptstr. 4-6 Wickede (Ruhr) Germany

Tacrolimus Ointment (Glenmark) – Packaging Defect (2022)

Defective Container: Tube split from side seam

Class IIILow

FDAJul 11, 2022Nationwide• Glenmark Pharmaceuticals Inc., USA

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SafeControl Handset (Wissner-Bosserhoff) – Reset Mode Concern (2022)

Tacrolimus Ointment (Glenmark) – Packaging Defect (2022)

Pentacam HR (Oculus) – IOL Calculator Alignment Issue (2022)

Pentacam AXL Wave (Oculus) – IOL Calculator Alignment Issue (2022)

Pentacam AXL/HR (Oculus) – IOL Calculator Alignment Issue (2022)

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

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

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

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

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

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

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

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

Medicina Oral Tip Syringe 0.5ml (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 Tip Syringe 2.5ml (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)