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Medical Devices Recalls

Medical equipment, implants, and diagnostic devices

38,779 Total Recalls

Velara Generator with an old Firmware version used with Philips Allura Xper Systems (Allura 15 & 12 (monoplane), Allura FD10C, Allura FD10F, Allura FD 10 F/C, Allura FD20, Allura XPER FD10/10, Allura XPER FD20 Biplane)

Philips Electronics North America

Class I - Dangerous

System may lock up.

Dec 9, 2016 Other Medical Devices View Details →

Human lgG Subclass Liquid Reagent Kits for use on the Siemens BN"IJ Analyser Product Code: NK001.T This kit is intended for qualifying human IgG subclasses 1,2,3 and 4 immunoglobulins in serum on the Beckman Coulter AU series. Meaurement of these immunoglobulins ais in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents

The Binding Site Group

Class I - Dangerous

Customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen excess and will yield spuriously low IgG4 results.

Sep 11, 2014 Other Medical Devices View Details →

Atrium Medical 3620-100: Oasis dual chamber drain with in-line connectors (2 Patient Tubes) Product Usage: To evacuate air and/or fluid from the chest cavity or mediastinum. To help re-establish lung expansion and restore breathing dynamics. To facilitate postoperative collection and reinfusion of autologous blood from the patient s pleural cavity or mediastinal area.

Atrium Medical

Class I - Dangerous

Outer Packaging is not sterile

Nov 29, 2016 Infusion Pumps Nationwide View Details →

Sekisui Diagnostics Ammonia L3K¿ Assay; Catalog Number: 293-80-91 and 293-10 For the IN VITRO quantitative measurement of ammonia concentration in plasma

Sekisui Diagnostics P.E.I.

Class I - Dangerous

Certain lots are showing an atypical decrease in optical density (OD) over time, which may result in an impact to performance at the high end of the linear range.

Nov 29, 2016 Diagnostic Equipment View Details →

DELFIA¿ PC with V3.0 Software, Fluorometer, for clinical use Product Number: 1235-8100 Product Usage: The Wallac 1235 AutoDELFIA automatic immunoassay system is designed to automatically perform assays using the DELFIA technology. DELFIA technology is based on the proven and widely used method of time resolved fluorometry

PerkinElmer Health Sciences

Class I - Dangerous

AutoDELFIA System with Version 3.0 Software: Potential plate loading failures

Dec 21, 2016 Diagnostic Equipment Nationwide View Details →

ProSpore 4 mL Ampoule Biological indicator for steam sterilization, contains Geobacillus stearothermophilus, Catalog Number: PS-6-50, contains 50 Ampoules/Box. Product Usage: Biological indicator for steam sterilization at 121 deg C intended for use by a health care provider to accompany products being sterilized through steam sterilization procedure and to monitor adequacy of sterilization.

Mesa Laboratories

Class I - Dangerous

Product resistance has fallen outside of label claim within expiry.

Apr 4, 2016 Diagnostic Equipment View Details →

Rigid Laryngostroboscopes The Rigid Laryngostroboscopes, Models 9106 and 9108 are intended to observe glottic action with the use of a stroboscopic light source. The instrument is inserted per-orally when indications consistent with the need for observation are observed.

Pentax of America

Class I - Dangerous

Pentax is initiating a Field Correction to revise the Instructions for Use of the Rigid Laryngostroboscopes Model 9106 and 9108.

Dec 12, 2016 Implants & Prosthetics Nationwide View Details →

Atrium Medical Oasis Blood Recovery Drains as follows: 3650-100 Oasis Blood Recovery drain with in-line connector 3652-100 Oasis Double Blood Recovery drain with in-line connectors - 2 patient lines connected by one Y connector Product Usage: To evacuate air and/or fluid from the chest cavity or mediastinum. To help re-establish lung expansion and restore breathing dynamics. To facilitate postoperative collection and reinfusion of autologous blood from the patient s pleural cavity or mediastinal area.

Atrium Medical

Class I - Dangerous

Outer Packaging is not sterile

Nov 29, 2016 Infusion Pumps Nationwide View Details →

Allura Xper FD20 722012 is intended for: Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and Electro Physiology(EP).

Philips Electronics North America

Class I - Dangerous

Due to a production error, screws were not tightened to specified torque. These screws may come loose from the C-arm shaft causing the C-arm to rotate uncontrolled.

Dec 1, 2016 Implants & Prosthetics View Details →

AutoDELFIA¿ Plate Processor , Fluorometer, for clinical use Product Number: 1235-5110 Product Usage: The Wallac 1235 AutoDELFIA automatic immunoassay system is designed to automatically perform assays using the DELFIA technology. DELFIA technology is based on the proven and widely used method of time resolved fluorometry

PerkinElmer Health Sciences

Class I - Dangerous

AutoDELFIA System with Version 3.0 Software: Potential plate loading failures

Dec 21, 2016 Diagnostic Equipment Nationwide View Details →

AFX Endovascular AAA System, Endoleak Type IIIA Common Name: AFX Bifurcated and Accessory Stent Grafts Classification Name: System, Endovascular Graft, Aortic Aneurysm Treatment The AFX Endovascular AAA System is intended for endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms (AAA).

Endologix

Class I - Dangerous

Endologix updated the Instructions for Use (IFU) and implemented modifications to the AFX Endovascular AAA System (AFX System).

Dec 27, 2016 Implants & Prosthetics Nationwide View Details →

Human Lambda Free SPAPlus Kit Product Code: LK018.S Freelite aids in the detection and monitoring of Multiple Myeloma and related diseases.

The Binding Site Group

Class I - Dangerous

Calibration curve activity has increased over time in the kit lots listed.

Nov 28, 2012 Diagnostic Equipment View Details →

Fresenius 2008K@home Series : Hemodialysis System

Fresenius Medical Care Renal Therapies Group

Class I - Dangerous

When the UF Rate, Goal or Time is adjusted using the up and down arrow keys, and the change is cancelled by using the esc key, the cancelled UF Rate is actually being executed rather than rate displayed on the machine

Dec 21, 2016 Other Medical Devices Nationwide View Details →

Optilite Analyser, Product Code: IE700 Product Usage: The Thermo Scientific Indiko Clinical Chemistry Analyzer is a fully automated random access analyzer used to measure a variety of analytes that may be adaptable to the analyzer depending on the reagent used. The Indiko Glucose (H-K) test system, is intended for in vitro diagnostic use in the quantitative determination of the glucose concentration in human plasma on the Indiko analyzer. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemnia, and of pancreatic islet cell carcinoma.

The Binding Site Group

Class I - Dangerous

Potential risk of the Optilite lid/cover falling suddenly and causing injury when not placed in the fully open position.

May 13, 2015 Diagnostic Equipment Nationwide View Details →

APD Set with Cassette 3-Prong Peritoneal Dialysis Set Indicated for use in the treatment of patients with renal failure to provide PD fluid exchanges with Baxter HomeChoice PD systems in clinical and home use settings.

Baxter Healthcare

Class I - Dangerous

Customer complaints received for the presence of leaks

Dec 16, 2016 Other Medical Devices View Details →

Medacta International SA, M.U.S.T. Rod, REF 03.50.433, Size 5.5mm, Length 480mm, Type Straight, Mat Co-Cr-Mo The rods act as a connector between the different pedicle screws to create a stable construct for the stabilization and fusion of the lumbar and thoracic spine. Indications for Use: The M.U.S.T. pedicle screw system is intended for posterior non-cervical pedicle fixation (T1-S2/ilium) or anterolateral fixation (T8-L5). The pedicle screws are connected by 5.5mm Titanium alloy or CoCrMo rods to create a stable construct. The construct is secured using a set screw made of CoCrMo.

Medacta Usa

Class I - Dangerous

Damaged packaging, lack of sterility assurance

Dec 7, 2016 Other Medical Devices Nationwide View Details →

NucliSENS magnetic extraction reagents, For in vitro diagnostic use, Product Usage: NucliSENS miniMAG¿ is intended to be used for the extraction of total nucleic acids from biological specimens.

BioMerieux SA

Class I - Dangerous

A drift of the performance with the BK test (BK virus, worst case application) was observed for some silica batches of Magnetic Silica (MagSil). This is the same issue as in recall Z-2342-2016.

Nov 23, 2016 Diagnostic Equipment Nationwide View Details →

Smith & Nephew, RENASYS GO Negative Pressure Wound Therapy External Power Supply Unit, Rx only. Intended for patients who would benefit from a suction device to help promote wound healing by removing fluids, including irrigation and body fluids, wound exudates and infectious materials. Used for chronic, acute, traumatic, subacute, and dehisced wounds/ulcers/partial thickness burns/flaps/grafts.

Smith & Nephew

Class I - Dangerous

Lack of 510k clearance for design modification.

Nov 11, 2016 Infusion Pumps Nationwide View Details →

AcuMatch A-Series Connexion GXL Enhanced Polyethylene Acetabular Liner, 15, +5 mm Lateralized, 36 mm I.D., Size J.

Exactech

Class I - Dangerous

Products were labeled with incorrect Global Trade Item Numbers. The GTIN on the label identifies the devices as another.

Nov 7, 2016 Other Medical Devices View Details →

AFX Endovascular AAA System, Endoleak Type: IIIB Common Name: AFX Bifurcated and Accessory Stent Grafts Classification Name: System, Endovascular Graft, Aortic Aneurysm Treatment The AFX Endovascular AAA System is intended for endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms (AAA).

Endologix

Class I - Dangerous

Endologix updated the Instructions for Use (IFU) and implemented modifications to the AFX Endovascular AAA System (AFX System).

Dec 27, 2016 Implants & Prosthetics Nationwide View Details →