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Veradius Unity C-arm (Philips) – Puerto Rico Delivery Issue (2023)

Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion systems that have been delivered to Puerto Rico without a warning label and the Source-to-Skin Distance Spacer (Tube-spacer) is missing.

High

FDAOct 4, 2023Nationwide• Philips North America

First Response Pregnancy Test (Family Dollar) – Temperature Storage Issue (2023)

Products were stored outside of labeled temperature requirements.

Low

FDAOct 4, 2023AL, AZ, AR +21 more• Family Dollar Stores, Llc.

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Veradius Unity C-arm (Philips) – Puerto Rico Delivery Issue (2023)

First Response Pregnancy Test (Family Dollar) – Temperature Storage Issue (2023)

Dentemp Dental Product (Family Dollar) – Temperature Storage Issue (2023)

Fixodent Adhesive (Family Dollar) – Temperature Storage Issue (2023)

FloTrac Sensor with VAMP (Edwards Lifesciences) – Flushing Difficulty (2023)

Blood Uric Acid Monitoring System (Visgeneer) – Unapproved Distribution (2023)

Hillrom Progressa+ Bed (Baxter) – Static Electricity Risk (2023)

TruWave Pressure Monitoring Set (Edwards Lifesciences) – Flushing Difficulty (2023)

CardioMEMS Patient System (St. Jude Medical) – Power Connector Risk (2023)

Marijuana Test Strip (Family Dollar) – Temperature Storage Issue (2023)

Tina-quant D-Dimer Test (Roche) – Result Elevation Issue (2023)

DRX Revolution X-Ray System (Carestream) – Electrical Component Failure (2023)

DRX-Revolution Mobile X-Ray (Carestream) – Generator Failure Risk (2023)

ACMI Roller Bar Electrodes (Olympus) – Incorrect Pouch Labeling (2023)

Coapt ControlSeal Electrode (Coapt) – Burn/Blistering Risk (2023)

STAT-Site M BHB Test Strips (Unknown) – Performance Degradation (2023)

Edge Biologicals Sterile Water (Edge Biologicals) – Packaging Mislabeling (2023)

EVIS EXERA III Videoscope (Olympus) – Sterilization Failure (2023)

Coapt Dome Electrode (Coapt) – Burn/Blistering Risk (2023)

LIFEPAK 15 (Physio-Control) – Battery Pin Looseness (2023)