Medical Devices Recalls
Defective surgical instruments, diagnostic equipment, and health device recalls.
Gentuity HF-OCT Imaging System Model G10-01; Software version 23.2.13;
The potential for repeated frames during HF-OCT pullback when using the Gentuity HF-OCT Console (software version 21.11 to 23.3.13) with the Vis-Rx and Vis-Rx Prime catheters. This correction is intended to ensure that users are fully informed of how to recognize, avoid, and mitigate this condition to maintain accurate longitudinal (length) measurements during OCT imaging.
Cytal Wound Matrix 2-Layer 10x15 cm. Product ID: WSM1015.
Increased rate of out-of-specification endotoxin results.
ARTIS Pheno VE30A and VE40A, Model 10849000
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.
Arjo Tenor mobile passive patient lift, Model Numbers KHA1000 US and KHA1010 US
An internal component of the actuators in a certain production batch may not meet the required mechanical strength. This could result, in the worst case scenario, in a sudden loss of the actuator's ability to hold the load, leading to rapid and uncontrolled downward movement of the lifting arm.
Philips Spectral CT on Rails. Model Number: 728334.
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.
Yeastone Broth, 11ML, 10/BOX YY3462
Products may report incorrect AST results during quality control. Health consequences may include delayed response or the need to change to another antifungal agent if laboratory ignores Quality Control test result.
LinkBio CORE Workstation, a component of the CORE Shoulder System. Product Code:...
The CORE Workstation may display an incorrect "Planning Date " when viewing cases on the "Start Case" menu screen.
B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG. Model Num...
Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG DR. Mode...
Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
React Health PHOENIX 5L Oxygen Concentrator
Devices which did not meet internal quality specifications were inadvertently distributed.
B. Barun Hemodialysis Bloodlines, StreamLine Bloodline Long Version, FMC. Model ...
Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
Cytal Wound Matrix 2-Layer 5x5 cm. Product ID: WSM0505.
Increased rate of out-of-specification endotoxin results.
CENTURION Circumcision Kit, Medline Kit Number/SKU CIT7050F
On lot of Sterile Circumcision Kits was distributed without the required sterilization process and is therefore not sterile.
Cytal Wound Matrix 2-Layer 7x10 cm. Product ID: WSM0710.
Increased rate of out-of-specification endotoxin results.
Brand Name: Elegance¿ Anterior Cervical Plate Product Name: ELEGANCE 1 LEVEL CE...
Due to a quality issue regarding the presence of burr on the finished cervical plate product.
iLet Ace Pump Kit REF: BB1001 iLet Dosing Decision Software
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.
Cytal Burn Matrix 10x15 cm. Product ID: BMM1015.
Increased rate of out-of-specification endotoxin results.
B Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 4.8MM PUMP SEGMENT. Model N...
Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
B. Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 2.6MM PUMP SEGMENT. Model ...
Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
Instinct Plus Endoscopic Clipping Device REF: G58010 Rx Only, Sterile EO
Due to increased in complaints their is the potential for endoscopic clipping device to malfunction.
Philips AneurysmFlow. Model Number: 001015. AneurysmFlow is a software medic...
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.
COOK MEDICAL NCompass¿ Nitinol Stone Extractor: Reference Part Number C-NTSE-2....
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
COOK MEDICAL Approach CTO-18 Micro Wire Guide, Reference Part Number CMW-14-190-...
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor...
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.