All Recalls

Increased difficulty in installing the centrifuge bowl onto the centrifuge bowl holder. Improper installation may cause the centrifuge bowl to dislodge, resulting in a broken bowl during the prime cycle or treatment phase, leading to a delay in patient treatment and blood loss.

Potential safety issue involving the Mean Aneurysm Flow Amplitude (MAFA) ratio of AneurysmFlow (Interventional Tool). Philips has determined that the MAFA ratio does not provide reliable prognostic information regarding aneurysm occlusion following Flow Diverter Stent treatment, however despite being stated in the IUF, it is being relied on for making clinical decisions.

it was found that in versions 1.3.7, 1.4.2, and 1.4.3, the Lock Screen and Limited Access Passcode Screen on the iLet graphical user interface (GUI) include certain icons displayed in the status bar that are active, thereby allowing the user to bypass those screens when those icons on the status bar are pressed, allowing unauthorized access while the device is in Limited Access Mode. A Health Risk associated with Limited access mode includes severe hypoglycemia due to unauthorized access to the iLet if someone were to make unauthorized meal announcements or stopped insulin delivery.

Due to a quality issue regarding the presence of burr on the finished cervical plate product.

Increased rate of out-of-specification endotoxin results.

Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.

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.

During 3D acquisitions, lighter and darker patient images may be captured, which may result in less accurate 3D reconstruction. The variation of brightness is a result of a constant unregulated medium dose and the angular change of patient diameter caused by rotational acquisition. This may result in unintentional low-dose radiation exposure to a patient.

On lot of Sterile Circumcision Kits was distributed without the required sterilization process and is therefore not sterile.

May be temperature abused, which may result in growth of Clostridium botulinum

Soy Lecithin listed in ingredients statement, but Soy is not mentioned in the contains statement.

Soy Lecithin listed in ingredients statement, but Soy is not mentioned in the contains statement.

Label declares cream cheese but does not declare milk

FDA analysis revealed the presence of undeclared sildenafil

Products contain banned sweetener: cyclamates.

FDA analysis revealed the presence of undeclared sildenafil

Products contain banned sweetener: cyclamates.

Potential Salmonella Contamination

Soy Lecithin listed in ingredients statement, but Soy is not mentioned in the contains statement.

FDA analysis revealed the presence of undeclared sildenafil and Tadalafil