FDA Device Recalls

Class IIOngoing

Philips Spectral CT on Rails. Model Number: 728334.

PHILIPS MEDICAL SYSTEMS

Philips has identified three software issues: 1. During a continuous CT (CCT) scan, there is the potential that the Gantry could remain at the current scan position after pressing Go. 2. Potential where the message of Previous Surview Exists Select Previous Surview? <Yes> or <No> should display but does not appear. 3. After performing Surview and planning the Brain Helical acquisition by setting Brain Area DoseRight Index to increase the dose, there is the potential that the Define Head Area option in the context menu is grayed out.

March 7, 2026 · DeviceView details →

ARTIS pheno and ARTIS Icono biplane, floor and ceiling. Model Numbers 10849000, 11327600, 11328100, 11327700.

LSL Healthcare Wound Closure Tray, Model/Catalog Number: 7554

LSL Healthcare, Foley Urine Collection Kit, Model/Catalog Number: 1555

VACUUM BAG SU LARGE, Non-sterile specimen container, Model/Catalog Number: 68409SS

LSL Healthcare, Standard Central Line Dressing Change Kit, Model/Catalog Number: 2717J

ARTIS Icono biplane, floor and ceiling.: ARTIS icono biplane Model 11327600. ARTIS icono ceiling Model 11328100. ARTIS icono floor Model 11327700. interventional fluoroscopic x-ray system

LSL Healthcare, Central Line Dressing Kit, Model/Catalog Number: 2717H

LSL Healthcare, IV Start Kit, Model/Catalog Number: 3131

ARTIS pheno, Model 10849000. interventional fluoroscopic x-ray system

LSL Healthcare, Infant Central Line Dressing Change Kit, Model/Catalog Number: 2925H

Philips Spectral CT on Rails. Model Number: 728334.

CUSA Clarity C7000 Console, Software Version: 2.1.1.909. Ultrasonic surgical aspirator system.

The product is a handheld ultraviolet-C germicidal wand and contains a combination of five UV-A and UV-C LED lights. The product comes in two configurations: UV-C x 1; UV-A x 4, or UV-C x 2; UV-A x 3. The product has two peak emission wavelengths at 274 nm and 397 nm.

The product is a handheld ultraviolet-C germicidal wand and contains two low-pressure mercury bulbs with a peak emission wavelength at 254 nm.

COOK MEDICAL Arterial Pressure Monitoring Tray, Reference Part Number APMY-2.5-15-0-2.5 , Order Number G58412; Reference Part Number APMY-4.0-21J-1-12, Order Number G58419

Melker Universal Cuffed Emergency Cricothyrotomy Catheter Set: Reference Part Number C-TCCSB-500-UNI, Order Number G32193; Reference Part Number C-TCCSB-500-UNI-01, Order Number G47665.

COOK MEDICAL Cook¿ Strange Bile Duct Stone Exploration Set: Reference Part Number C-CSRC-7.5D-40-STRANGE, Order Number G09108

COOK MEDICAL Wayne Pneumothorax Set: Reference Part Number C-UTPT-1020-WAYNE-IMH, Order Number G56532; Reference Part Number C-UTPT-1400-WAYNE-112497-IMH, Order Number G56535.