🔍 RecallPedia
🏥

Medical Devices Recalls

Medical equipment, implants, and diagnostic devices

38,779 Total Recalls

CERTAIN(R) BELLATEK(R) TITANIUM ABUTMENT 3.4MM, Item Number IEDAT3 - Product Usage: BIOMET3i Restorative products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible

Biomet 3i

Class I - Dangerous

During manufacturing, the screw stop ledge was not made to specification and location within the abutment, resulting in the screw head seating deeper in the abutment with no positive stop.

Feb 26, 2019 Implants & Prosthetics Nationwide View Details →

CERTAIN(R) BELLATEK(R) TIN ABUTMENT 3.4MM, Item Number IEDAN3 - Product Usage: BIOMET3i Restorative products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible

Biomet 3i

Class I - Dangerous

During manufacturing, the screw stop ledge was not made to specification and location within the abutment, resulting in the screw head seating deeper in the abutment with no positive stop.

Feb 26, 2019 Implants & Prosthetics Nationwide View Details →

Philips EPIQ and Affiniti Ultrasound Systems with software version 4.0: Models EPIQ 5G, EPIC 5C, EPIQ 5W, EPIQ 7G, EPIC 7C, EPIQ 7W, EPIZ CVx, Affiniti 30, Affiniti 50, and Affiniti 70. Product Usage: The intended use of the EPIQ, EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound Systems is diagnostic ultrasound imaging and fluid flow analysis of the human body with the following Indications for Use: Abdominal, Cardiac Adult, Cardiac other (Fetal), Cardiac Pediatric, Cerebral Vascular, Cephalic (Adult), Cephalic (Neonatal), Fetal/Obstetric, Gynecological, Intraoperative (Vascular), Intraoperative (Cardiac), Musculoskeletal (Conventional), Musculoskeletal (Superficial), Other: Urology, Pediatric, Peripheral Vessel, Small Or Jan (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transrectal, Transvaginal. When integrated with Philips EchoNavigator, the systems can assist the interventionist and surgeon with image guidance during treatment of cardiovascular disease in which the procedure uses both live X-ray and live Echo Guidance.

Philips Ultrasound

Class I - Dangerous

There is a potential that the image of one patient could get unexpectedly moved into another patient's folder when the user is using the Edit functionality on the Patient Data Entry (PDE) screen of the device.

Apr 29, 2019 Diagnostic Equipment Nationwide View Details →

SenTec Neonatal Starter Set with and without Service Gas (2 Chargers each) - Product Usage: is indicated for continuous, non-invasive monitoring of carbon dioxide tension and oxygen tension as well as oxygen saturation and pulse rate in adult and pediatric patients. In neonatal patients the SDMS is indicated for carbon dioxide and oxygen tension monitoring only. Oxygen tension monitoring is contraindicated for patients under gas anesthesia.

SenTec AG

Class I - Dangerous

There is an increased chance (approx. 5%) of no electrolyte or a reduced amount of electrolyte being applied to the sensor during the membrane change procedure.

May 2, 2019 Diagnostic Equipment Nationwide View Details →

Lantis 8.3 Commander, Model # 8148178 - Product Usage: Lantis Treatstation is to allow the radiation therapist to deliver treatment to the patient using the mevatron and all available accessories. This entails selecting a patient, selecting today s treatment for that patient, setting up and delivering the treatment fields and recording the delivered treatment. Treatstation supports auto sequencing, a process of automatically downloading a group of fields or segments from the verification and record system to the control of the linear accelerator sequentially, without user intervention. In addition, Lantis Treatstation supports intensity modulation, a process of shaping, modifying and moving the beam around a target to maximize the dose at the target and minimize the dose to normal structures.

Siemens Medical Solutions USA

Class I - Dangerous

Potentially affected by the Microsoft Windows Remote Desktop Protocol (RDP) vulnerability

Jul 10, 2019 Infusion Pumps View Details →

SenTec Membrane Changer Set (1 charger plus 1 insert) - Product Usage: is indicated for continuous, non-invasive monitoring of carbon dioxide tension and oxygen tension as well as oxygen saturation and pulse rate in adult and pediatric patients. In neonatal patients the SDMS is indicated for carbon dioxide and oxygen tension monitoring only. Oxygen tension monitoring is contraindicated for patients under gas anesthesia.

SenTec AG

Class I - Dangerous

There is an increased chance (approx. 5%) of no electrolyte or a reduced amount of electrolyte being applied to the sensor during the membrane change procedure.

May 2, 2019 Diagnostic Equipment Nationwide View Details →

Dimension¿ Ferritin (FERR) Flex¿ reagent cartridge DM FERR Product Usage: The FERR Flex reagent cartridge is intended to be used on the Dimension RxL clinical chemistry system to quantitatively measure ferritin in human serum and plasma. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis and iron deficiency anemia.

Siemens Healthcare Diagnostics

Class I - Dangerous

Negative Bias with Lot EA9227.

Jul 15, 2019 Infusion Pumps Nationwide View Details →

The DABRA Laser (model RA-308) is designed to provide ultraviolet laser energy endovascularly through a catheter to occluded lesions in the peripheral arteries to cross them. The system is a self-contained unit that consists of a light source unit and a single use catheter. The light source contains a microprocessor with software to provide safety features and a user-friendly interface. The laser operates by producing a high current discharge within a chamber that is filled with rare gases and halogen. The discharge produces pulses of UV light, which is amplified by reflecting the energy within the resonating chamber many times. The output is directed to the desired target location by the catheter. A footswitch connected to the light source controls the laser action.

Ra Medical Systems

Class I - Dangerous

Lasers/Catheters did not calibrate during set-up prior to use.

Feb 15, 2018 Surgical Instruments View Details →

Workstation, G2, Configured (P/N 000-0241)

Intellijoint Surgical

Class I - Dangerous

Apple has determined that, in a limited number of older generation 15-inch MacBook Pro Units, the battery may overheat and pose a fire safety risk. To date, Intellijoint has distributed, 15-inch MacBook Pros which are the Workstation component (affected P/N 000-0241) in the Intellijoint HIP System.

Jun 28, 2019 Other Medical Devices View Details →

Logolas Laser Projection Series

Gk Photonics

Class I - Dangerous

The User Remote Interlock Dongle provided with the E-Stop Remote is not sufficient to fully comply with the FDA's Manual Reset Mechanism requirement for laser projectors and could unintentionally expose the user and/or observers to high power laser radiation. It needs to be replaced for safety reasons.

Jul 10, 2019 Other Medical Devices View Details →

ELLIPSE VR, Tiered-therapy cardioverter/defibrillator, REF: CD1411-36Q, UDI: 05414734507738

St Jude Medical

Class I - Dangerous

Electrical failures were identified in cardioverter defibrillators (ICDs) due to damaged aluminum wires. ICDs may contain electrical wire connections which may not be completely insulated. The potential patient impact could be the inability to deliver high voltage therapy. There is no available option to verify the vulnerability status for implanted devices.

Jun 20, 2019 Other Medical Devices Nationwide View Details →