All recalls8,501 total
Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility.
Due to complaints of device breakage at the traction force gauge to handle joint.
Products were incorrectly labeled with a 5-year shelf life. The approved and validated shelf life is four years.
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.
Undeclared allergen ingredients (sesame and wheat) in Zaatar Spice mix.
Gorditas and Doraditas are missing the following allergens in product label: Wheat and Soy
Gorditas and Doraditas are missing the following allergens in product label: Wheat and Soy
Lack of Assurance of Sterility
Software issue that renders the touch screen unresponsive.
In some foreseeable use conditions, the products can expose nearby persons to UVC radiation at levels significantly above limits recommended by international safety guidelines for skin and eye exposure.
In some foreseeable use conditions, the Products can expose nearby persons to UVC radiation at levels significantly above limits recommended by international safety guidelines for skin and eye exposure.
Foreign Object (Glass)
Foreign Object (Glass)
Lack of Assurance of Sterility
Potential that mis-ordered frames in Vue Motion during dynamic cine runs may cause images frames to display out of sequence.
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Affected products were incorrectly labeled as Tornier HRS Max products. These parts are compatible with the Tornier HRS system only, and are incompatible with the Tornier HRS Max system.
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Calibrated Output was not calculating correctly - UV Sensor GAIN being applied was incorrect - GAIN seemed to be "4/5" instead of "7" (counts were at ~1000 instead of ~5000).
Calibrated Output was not calculating correctly - UV Sensor GAIN being applied was incorrect - GAIN seemed to be "4/5" instead of "7" (counts were at ~1000 instead of ~5000).
Calibrated Output was not calculating correctly - UV Sensor GAIN being applied was incorrect - GAIN seemed to be "4/5" instead of "7" (counts were at ~1000 instead of ~5000).
Undeclared allergen Milk. The presence of the milk allergen in the product was found to exceed acceptable levels despite the product being labeled with the statement *May contain milk. *
Product labeling includes a fetal indication for use that is not cleared under its 510(k).
Foreign objects are glass varying in size from 1-3cm long and 2-4mm wide.
Foreign objects are glass varying in size from 1-3cm long and 2-4mm wide.
Foreign objects are glass varying in size from 1-3cm long and 2-4mm wide.
Foreign objects are glass varying in size from 1-3cm long and 2-4mm wide.
Foreign objects are glass varying in size from 1-3cm long and 2-4mm wide.
Foreign objects are glass varying in size from 1-3cm long and 2-4mm wide.
Foreign objects are glass varying in size from 1-3cm long and 2-4mm wide.
Foreign objects are glass varying in size from 1-3cm long and 2-4mm wide.
Foreign objects are glass varying in size from 1-3cm long and 2-4mm wide.
Undeclared Allergen: Milk
Foreign objects are glass varying in size from 1-3cm long and 2-4mm wide.